Polypropylene Synthetic Non-Absorbable Suture Suppliers
Limit companies to: Worldwide USA
W. l. Gore & Associates, Inc. | Address: P.O. Box 2400, Flagstaff, Arizona 86003-2400, USA 
www.goremedical.com | Send Inquiry | Phone: +1-(928)-779-2771, 800 -437-8181
FDA Registration: 3013164176
Products: Sutures, Dural Substitute, Catheter Introducers (FDA Code: DYB), Cruciate Ligament Tool, Vascular Grafts, Surgical Patches, ...
W. l. Gore & Associates, Inc. produces a wide range of products for fabric laminates, medical implants, electronic signal transmission & microfiltration. Our Gore Excluder® AAA endoprosthesis is a more...
www.goremedical.com | Send Inquiry | Phone: +1-(928)-779-2771, 800 -437-8181
FDA Registration: 3013164176
Products: Sutures, Dural Substitute, Catheter Introducers (FDA Code: DYB), Cruciate Ligament Tool, Vascular Grafts, Surgical Patches, ...
W. l. Gore & Associates, Inc. produces a wide range of products for fabric laminates, medical implants, electronic signal transmission & microfiltration. Our Gore Excluder® AAA endoprosthesis is a more...
Sutura Inc. | Address: 17080 Newhope St., Fountain Valley, California 92708, USA
www.suturaus.com | Send Inquiry | Phone: +1-(714)-437-9801, 800-884-8550
FDA Registration: 2031768 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Aortic Punches, General Sutures/Needles, Aortic Punches Tip Conical, Cardiac Bypass Assist Tools, Anastomosis Assist Aortic Punch, Cranial Sutures, Chromic Sutures, ...
Sutura Inc. offers a line of minimally invasive vessel closure devices to suture the puncture created in the femoral artery during catheter-based procedures, primarily in the fields of cardiology & ra more...
www.suturaus.com | Send Inquiry | Phone: +1-(714)-437-9801, 800-884-8550
FDA Registration: 2031768 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Aortic Punches, General Sutures/Needles, Aortic Punches Tip Conical, Cardiac Bypass Assist Tools, Anastomosis Assist Aortic Punch, Cranial Sutures, Chromic Sutures, ...
Sutura Inc. offers a line of minimally invasive vessel closure devices to suture the puncture created in the femoral artery during catheter-based procedures, primarily in the fields of cardiology & ra more...
Abbott Vascular Devices | Address: 400 Saginaw Drive, Redwood City, California 94063-4749, USA
www.abbottvasculardevices.com | Phone: +1-(650)-474-3000
Year Established: 1888
Products: Active Closure Devices, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Cardiac Bypass Assist Tools, Heart Stabilization Tools, Peripheral Guidewires, Carotid Stent Systems (FDA Code: NIM), ...
Abbott Vascular Devices concentrates on medical device innovations with world-class pharmaceuticals to deliver solutions for the treatment of vascular diseases. We render a portfolio of endovascular p more...
www.abbottvasculardevices.com | Phone: +1-(650)-474-3000
Year Established: 1888
Products: Active Closure Devices, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Cardiac Bypass Assist Tools, Heart Stabilization Tools, Peripheral Guidewires, Carotid Stent Systems (FDA Code: NIM), ...
Abbott Vascular Devices concentrates on medical device innovations with world-class pharmaceuticals to deliver solutions for the treatment of vascular diseases. We render a portfolio of endovascular p more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Theragenics Corporation | Address: 5203 Bristol Industrial Way, Buford, Georgia 30518, USA
www.theragenics.com | Phone: +1-(770)-271-0233
FDA Registration: 3013378804 Year Established: 1981 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: CE Certified
Products: Needles, Radiation Plaques, Catheter Introducers (FDA Code: DYB), Wound Closures, Vitreoretinal Surgery, Radiation Plaques, Bone Wax (FDA Code: MTJ), ...
Theragenics Corporation is a medical device company serving the cancer treatment and surgical markets. We offer specialty needles, RF Devices, implanter and introducer products, surgery, vascular, onc more...
www.theragenics.com | Phone: +1-(770)-271-0233
FDA Registration: 3013378804 Year Established: 1981 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: CE Certified
Products: Needles, Radiation Plaques, Catheter Introducers (FDA Code: DYB), Wound Closures, Vitreoretinal Surgery, Radiation Plaques, Bone Wax (FDA Code: MTJ), ...
Theragenics Corporation is a medical device company serving the cancer treatment and surgical markets. We offer specialty needles, RF Devices, implanter and introducer products, surgery, vascular, onc more...
Ethicon, Inc. | Address: P.O. Box 151,Route 22 West, Somerville, New Jersey 08876, USA
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Ethicon Endo-Surgery, Inc. | Address: 4545 Creek Road, Cincinnati, Ohio 45242-2839, USA
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Tissue Forceps, ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Tissue Forceps, ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Surgical Specialties Corporation | Address: 100 Dennis Drive, Reading, Pennsylvania 19606, USA
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Trephines, Eyelid Specula, Disposables, Corneal Donor Button Punch, Punctum Plugs (Punctal Plugs), ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer more...
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Trephines, Eyelid Specula, Disposables, Corneal Donor Button Punch, Punctum Plugs (Punctal Plugs), ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer more...
KMI Kolster Methods, Inc. | Address: 3185 Palisades Dr., Corona, California 92880, USA
www.silhouettesutures.com | Phone: +1-(951)-737-5476, 866-412-7867
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Volumetric Infusion Pumps, Catheter Accessories (FDA Code: KGZ), Infusion Pumps, Ambulatory Pumps, PCA Pumps, Infusion Pump, Dual-Channel Volumetric Infusion Pump, ...
KMI Kolster Methods, Inc. specializes in offering various surgical and medical products. Our endoscopic surgery instruments are used in plastic and reconstructive surgery. Our line of products range f more...
www.silhouettesutures.com | Phone: +1-(951)-737-5476, 866-412-7867
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Volumetric Infusion Pumps, Catheter Accessories (FDA Code: KGZ), Infusion Pumps, Ambulatory Pumps, PCA Pumps, Infusion Pump, Dual-Channel Volumetric Infusion Pump, ...
KMI Kolster Methods, Inc. specializes in offering various surgical and medical products. Our endoscopic surgery instruments are used in plastic and reconstructive surgery. Our line of products range f more...
Silhouette Lift | Address: 250 east rincon, ste 104, corona, California 92879, USA
Phone: +1-(951)-7347701
FDA Registration: 3007009755
Products: Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), ...
Silhouette Lift focuses on polyglycolic acid synthetic absorbable sutures and polypropylene synthetic non-absorbable sutures. more...
Phone: +1-(951)-7347701
FDA Registration: 3007009755
Products: Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), ...
Silhouette Lift focuses on polyglycolic acid synthetic absorbable sutures and polypropylene synthetic non-absorbable sutures. more...
Applied Dental, Inc. | Address: 544 E. Weddell Drive, Suite 9, Sunnyvale, California 94089-2123, USA
www.applied-dental.com | Send Inquiry | Phone: +1-(408)-541-1393
FDA Registration: 2954705 Annual Revenues: < USD 1 Million
Products: Non-Absorbable Sutures (FDA Code: GAO), Surgical Drapes & Packs (FDA Code: KKX), Toothbrushes, Surgical Sutures, Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), ...
Applied Dental, Inc. offers innovative tools for dentistry. We offer surgical, restorative and hygiene products. We provide thermoplastic drill templates, intra-oral tips, and inter-dental brush syste more...
www.applied-dental.com | Send Inquiry | Phone: +1-(408)-541-1393
FDA Registration: 2954705 Annual Revenues: < USD 1 Million
Products: Non-Absorbable Sutures (FDA Code: GAO), Surgical Drapes & Packs (FDA Code: KKX), Toothbrushes, Surgical Sutures, Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), ...
Applied Dental, Inc. offers innovative tools for dentistry. We offer surgical, restorative and hygiene products. We provide thermoplastic drill templates, intra-oral tips, and inter-dental brush syste more...
Fen Dental Mfg., Inc. | Address: 2665 West 81st St., Hialeah, Florida 33016, USA
www.fendental.com | Send Inquiry | Phone: +1-(305)-556-5259
FDA Registration: 1058077
Products: Dental Needles, Dental Syringes, Scalpel Blade (FDA Code: GES), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), ...
Fen Dental Mfg., Inc. specializes in the production of dental products. Our products include FenLED, halogen curing units, Sunclave 1525SA, dental syringes, brushes for prophylaxis, dental handles and more...
www.fendental.com | Send Inquiry | Phone: +1-(305)-556-5259
FDA Registration: 1058077
Products: Dental Needles, Dental Syringes, Scalpel Blade (FDA Code: GES), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), ...
Fen Dental Mfg., Inc. specializes in the production of dental products. Our products include FenLED, halogen curing units, Sunclave 1525SA, dental syringes, brushes for prophylaxis, dental handles and more...
Kollsut Scientific Corporation | Address: 3286 North 29th Court, Hollywood, Florida 33020, USA
www.kollsut.com | Send Inquiry | Phone: +1-(630)-290-5746
FDA Registration: 3005953126
Products: IV Catheters, Surgical Sutures, I.V. Cannula, 3-Way Stop Cock, Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), ...
Kollsut Scientific Corporation is a manufacturer and distributor of surgical sutures & disposables. We specialize in surgical sutures, surgical and medical disposables, IV catheters, and safety IV cat more...
www.kollsut.com | Send Inquiry | Phone: +1-(630)-290-5746
FDA Registration: 3005953126
Products: IV Catheters, Surgical Sutures, I.V. Cannula, 3-Way Stop Cock, Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), ...
Kollsut Scientific Corporation is a manufacturer and distributor of surgical sutures & disposables. We specialize in surgical sutures, surgical and medical disposables, IV catheters, and safety IV cat more...
Demetech Corp. | Address: 3530 N.w. 115th Ave., Miami, Florida 33178, USA
Phone: +1-(305)-597-5277
FDA Registration: 1064584
Products: Forceps (FDA Code: HTD), Scissors, Sutures, Gastroenterologic Needle Holder (FDA Code: FHQ), Cohesive Bandages, Blood Pressure Monitors, ...
Demetech Corp. offers medical products and equipment.Our products include disposable surgeon's gloves, cotton applicator, blood pressure monitors/kit, suture, polyglycolic acid, surgical nylon suture, more...
Phone: +1-(305)-597-5277
FDA Registration: 1064584
Products: Forceps (FDA Code: HTD), Scissors, Sutures, Gastroenterologic Needle Holder (FDA Code: FHQ), Cohesive Bandages, Blood Pressure Monitors, ...
Demetech Corp. offers medical products and equipment.Our products include disposable surgeon's gloves, cotton applicator, blood pressure monitors/kit, suture, polyglycolic acid, surgical nylon suture, more...
Hu-Friedy | Address: 3232 N.Rockwell, Chicago, Illinois 60618-5982, USA
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
Grams Suture Corp. | Address: 604 Menteth Point Drive, Millersville, Maryland 21108, USA
Products: Natural Absorbable Suture (FDA Code: GAL), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), Silk Non-Absorbable Suture (FDA Code: GAP), ...
Grams Suture Corp. specializes in offering surgical appliances and supplies. more...
Products: Natural Absorbable Suture (FDA Code: GAL), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), Silk Non-Absorbable Suture (FDA Code: GAP), ...
Grams Suture Corp. specializes in offering surgical appliances and supplies. more...
Tornier Inc. | Address: 100 Cummings Center, Suite 444c, Beverly, Massachusetts 01915, USA
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
Centurion Medical Products | Address: 301 Catrell Drive, Howell, Michigan 48843, USA
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Scissors, Iris Scissors, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Scissors, Iris Scissors, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
Sponsored Links
EMAIL INQUIRY to 1 to 20 of 52 Polypropylene Synthetic Non-Absorbable Suture suppliers Page: [1] 2 3 
FDA Code / Regulation: GAW / 878.5010
Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.
Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." See 878.1(e) for the availability of this guidance document.
