Wire Cutters Suppliers
Limit companies to: Worldwide USA
K.K. Metallic Industries | Address: 21/277, Maharaja Road, Sialkot 51310, Pakistan
www.kkmetallic.com | Send Inquiry | Phone: +92-(52)-4586239
Products: Cosmetic Surgery, Needle Holder (Serrated), Bone Clamp (FDA Code: HXD), Coronary Needle Holders, Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Crile Wood Needle Holder, ...
K.K. Metallic Industries provides surgical instruments like forceps, obstetrical retractors, self-retaining pliers, surgical adapter to the cord, scissors, wire cutter, speculum, umbilical scissors, d more...
www.kkmetallic.com | Send Inquiry | Phone: +92-(52)-4586239
Products: Cosmetic Surgery, Needle Holder (Serrated), Bone Clamp (FDA Code: HXD), Coronary Needle Holders, Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Crile Wood Needle Holder, ...
K.K. Metallic Industries provides surgical instruments like forceps, obstetrical retractors, self-retaining pliers, surgical adapter to the cord, scissors, wire cutter, speculum, umbilical scissors, d more...
Kashmir Surgical Co. | Address: Maharaja Road, Sialkot 22161, Pakistan
Phone: +92-(52)-4586239, 4597140
FDA Registration: 8043753
Products: Forceps (FDA Code: HTD), Surgical Holloware Instrument, Soft Ear Speculum (FDA Code: EPY), Ophthalmic Suture Scissors (FDA Code: HNF), Ear Speculum (FDA Code: EPY), Surgical Knife (FDA Code: EMF), ...
Kashmir Surgical Co. are a manufacturer, exporter and global distributor of surgical, dental, veterinary, manicure & pedicure instruments. more...
Phone: +92-(52)-4586239, 4597140
FDA Registration: 8043753
Products: Forceps (FDA Code: HTD), Surgical Holloware Instrument, Soft Ear Speculum (FDA Code: EPY), Ophthalmic Suture Scissors (FDA Code: HNF), Ear Speculum (FDA Code: EPY), Surgical Knife (FDA Code: EMF), ...
Kashmir Surgical Co. are a manufacturer, exporter and global distributor of surgical, dental, veterinary, manicure & pedicure instruments. more...
Alphonso Corporation Pvt. Ltd. | Address: P.O. Box 1251, Sialkot 51310, Pakistan
www.alphonsocorp.com | Send Inquiry | Phone: +92-(52)-3255645, 3254135
Products: Adson Tissue Forceps, Bone Curettes, Adjustable Bone Holding Forceps, Bone Cutting Forceps, Bone Craft Osteotomes, Bone Cutting Forceps straight, ...
Alphonso Corporation Pvt. Ltd. manufactures and exports surgical, dental, manicure & all sorts of scissors. We are an ISO 9001 certified company. Our products include amalgam pluggers, probe explorers more...
www.alphonsocorp.com | Send Inquiry | Phone: +92-(52)-3255645, 3254135
Products: Adson Tissue Forceps, Bone Curettes, Adjustable Bone Holding Forceps, Bone Cutting Forceps, Bone Craft Osteotomes, Bone Cutting Forceps straight, ...
Alphonso Corporation Pvt. Ltd. manufactures and exports surgical, dental, manicure & all sorts of scissors. We are an ISO 9001 certified company. Our products include amalgam pluggers, probe explorers more...
Worth Field Enterprises | Address: P.O. Box # 998, Sialkot 51310, Pakistan
www.wfent.biz | Send Inquiry | Phone: +92-(524)-595265
Products: Bipolar Forceps, Biopsy Forceps, Adson Tissue Forceps, Artery Forceps, Ear & Nasal Dressing Forceps, Atraumatic Tissue Forceps, ...
Worth Field Enterprises is a manufacturer & exporter of surgical, manicure, medical and beauty instruments. We provide forceps, scissors, knives, retractors, orthopedic plastic shears, nasal specula & more...
www.wfent.biz | Send Inquiry | Phone: +92-(524)-595265
Products: Bipolar Forceps, Biopsy Forceps, Adson Tissue Forceps, Artery Forceps, Ear & Nasal Dressing Forceps, Atraumatic Tissue Forceps, ...
Worth Field Enterprises is a manufacturer & exporter of surgical, manicure, medical and beauty instruments. We provide forceps, scissors, knives, retractors, orthopedic plastic shears, nasal specula & more...
A.N.A Amity Impex | Address: A.N.A Square, Airport Road, Muradpur, Sialkot 51310, Pakistan
www.anaamity.com | Send Inquiry | Phone: +92-(52)-4268654
Quality: ISO-9001 Certified
Products: Scalpels, Disposable Scalpels, Disposable Surgical scalpels, Disposable Safety Scalpels, Stainless Disposable Scalpels, Flexible Retractor, ...
A.N.A Amity Impex is a manufacturer and exporter of surgical, dental, veterinary, manicure & pedicure implements. We are an ISO 9001:2000, pGMP and CE certified company. Our surgical instruments inclu more...
www.anaamity.com | Send Inquiry | Phone: +92-(52)-4268654
Quality: ISO-9001 Certified
Products: Scalpels, Disposable Scalpels, Disposable Surgical scalpels, Disposable Safety Scalpels, Stainless Disposable Scalpels, Flexible Retractor, ...
A.N.A Amity Impex is a manufacturer and exporter of surgical, dental, veterinary, manicure & pedicure implements. We are an ISO 9001:2000, pGMP and CE certified company. Our surgical instruments inclu more...
Saweez Surgical Corporation | Address: P. O. Box 2634, Sialkot 51310, Pakistan
www.saweez.com | Send Inquiry | Phone: +92-(52)-4592136
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Bone Holding Forceps, Dental Forceps, Specialty Surgical Instruments, ...
Saweez Surgical Corporation manufactures and exports dental instruments, surgical instruments & manicure products. Our surgical instruments include dissecting forceps, bone holding forceps, hand held more...
www.saweez.com | Send Inquiry | Phone: +92-(52)-4592136
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Bone Holding Forceps, Dental Forceps, Specialty Surgical Instruments, ...
Saweez Surgical Corporation manufactures and exports dental instruments, surgical instruments & manicure products. Our surgical instruments include dissecting forceps, bone holding forceps, hand held more...
Hilbro Private Limited | Address: P.O. Box 22, Sialkot, Pakistan
www.hilbrointl.com | Send Inquiry | Phone: +92-(52)-6526276-78
FDA Registration: 8040884 Year Established: 1961 Annual Revenues: USD 1-5 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Titanium Hemostatic Forceps, Titanium Micro Forceps, Titanium Micro Scissors, Titanium Cardiovascular Clamps, Titanium Needle Holders, ...
Hilbro Private Limited manufactures surgical and dental instruments. We are ISO 9002 and ISO 13485 certified, FDA registered & CE marked. Our product categories are diagnostics, scalpels, scissors, bo more...
www.hilbrointl.com | Send Inquiry | Phone: +92-(52)-6526276-78
FDA Registration: 8040884 Year Established: 1961 Annual Revenues: USD 1-5 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Titanium Hemostatic Forceps, Titanium Micro Forceps, Titanium Micro Scissors, Titanium Cardiovascular Clamps, Titanium Needle Holders, ...
Hilbro Private Limited manufactures surgical and dental instruments. We are ISO 9002 and ISO 13485 certified, FDA registered & CE marked. Our product categories are diagnostics, scalpels, scissors, bo more...
Chand Jee Mfg.Co. | Address: Jinnah Islamia College Road, P.O.Box: 1255, Sialkot, Pakistan
www.chandjee.com.pk | Send Inquiry | Phone: +92-(432)-580589
Annual Revenues: USD 1-5 Million Employee Count: ~80 Quality: ISO 9001 Certified
Products: Clamps, Vascular Clamps (FDA Code: DXC), Balloon Ureteral Dilators, Metal Skull Clamps, Disposable Sterile Umbilical Cord Clamps, Dilators, ...
Chand Jee Mfg.Co. manufactures and exports surgical & dental instruments, scissors & pliers of all sorts. We are accredited with ISO 9000-2000 certification. Our products are CE marked. Our product li more...
www.chandjee.com.pk | Send Inquiry | Phone: +92-(432)-580589
Annual Revenues: USD 1-5 Million Employee Count: ~80 Quality: ISO 9001 Certified
Products: Clamps, Vascular Clamps (FDA Code: DXC), Balloon Ureteral Dilators, Metal Skull Clamps, Disposable Sterile Umbilical Cord Clamps, Dilators, ...
Chand Jee Mfg.Co. manufactures and exports surgical & dental instruments, scissors & pliers of all sorts. We are accredited with ISO 9000-2000 certification. Our products are CE marked. Our product li more...
QSA Surgical (Pvt) Ltd. | Address: Ghuinke Daska Road .P.O.Box 1094, Sialkot 051310, Pakistan
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Uterine Packer (FDA Code: HDM), Hemostats (FDA Code: HRQ), Sterile ENT Wire Cutting Scissors (FDA Code: JYA), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Uterine Packer (FDA Code: HDM), Hemostats (FDA Code: HRQ), Sterile ENT Wire Cutting Scissors (FDA Code: JYA), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Spartech Instruments & Co. | Address: 60B , Small Industrial Estate, P .O. Box # 0000, Sialkot 51310, Pakistan
www.spartechinstruments.com | Send Inquiry | Phone: +92-(523)-0000000
FDA Registration: 3004892425
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Spartech Instruments & Co manufactures and exports surgical, dental and medical instruments. Our surgical instruments include diagnostic, anaesthesia, scalpels & knives, scissors, forceps, needle hold more...
www.spartechinstruments.com | Send Inquiry | Phone: +92-(523)-0000000
FDA Registration: 3004892425
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Spartech Instruments & Co manufactures and exports surgical, dental and medical instruments. Our surgical instruments include diagnostic, anaesthesia, scalpels & knives, scissors, forceps, needle hold more...
Conmed International | Address: Muhammad Pura, Punjab, Sialkot, Pakistan
www.conmedint.com | Send Inquiry | Phone: +92-(52)-4291726
Products: Orthopedics Accessory Instruments, Orthopedic Surgical Instruments, Minimally Invasive Hip Instruments, Orthopedic Surgical Instruments, Osteotomes, Orthopedics Instruments, Orthopedic Instruments, Condylar Buttress Plates for Right Leg, ...
Conmed International is a manufacturer and exporter of orthopedic instruments. Our product line includes depth gauge, hexagonal screw driver, socket wrench, bending press, drill bit, angled blade plat more...
www.conmedint.com | Send Inquiry | Phone: +92-(52)-4291726
Products: Orthopedics Accessory Instruments, Orthopedic Surgical Instruments, Minimally Invasive Hip Instruments, Orthopedic Surgical Instruments, Osteotomes, Orthopedics Instruments, Orthopedic Instruments, Condylar Buttress Plates for Right Leg, ...
Conmed International is a manufacturer and exporter of orthopedic instruments. Our product line includes depth gauge, hexagonal screw driver, socket wrench, bending press, drill bit, angled blade plat more...
M.J. Instruments Company (Pvt) Ltd. | Address: Small Industries Estate, Sialkot 22161, Pakistan
Phone: +92-(432)-256627
FDA Registration: 8043752
Products: Oxygen Nasal Catheter (FDA Code: BZB), Disposable Medical Scissors (FDA Code: JOK), Manual Rongeur (FDA Code: HAE), Percussor, Vibrator (FDA Code: GWZ), Fixed Size Cervical Dilator (FDA Code: HDQ), Gynecological Biopsy Forceps (FDA Code: HFB), ...
M.J. Instruments Company (Pvt) Ltd. is a manufacturer of cutting forceps, biopsy forceps, rongeurs, and anoscopes. more...
Phone: +92-(432)-256627
FDA Registration: 8043752
Products: Oxygen Nasal Catheter (FDA Code: BZB), Disposable Medical Scissors (FDA Code: JOK), Manual Rongeur (FDA Code: HAE), Percussor, Vibrator (FDA Code: GWZ), Fixed Size Cervical Dilator (FDA Code: HDQ), Gynecological Biopsy Forceps (FDA Code: HFB), ...
M.J. Instruments Company (Pvt) Ltd. is a manufacturer of cutting forceps, biopsy forceps, rongeurs, and anoscopes. more...
Armasa Traders | Address: First Floor, Lahore Motors, Opposite, Glaxy Hotel, Kashmir Road, Sialkot 51310, Pakistan
Phone: +92-(52)-401-1612
Products: Forceps (FDA Code: HTD), Wire Cutters (FDA Code: HXZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Wire Holding Forceps (FDA Code: HYA), Biopsy Forceps Cover (FDA Code: FFF), Disconnect Forceps (FDA Code: FJR), ...
Armasa Traders deals with forceps. Our products include biopsy forceps covers, disconnect forceps, forceps and wire holding forceps. more...
Phone: +92-(52)-401-1612
Products: Forceps (FDA Code: HTD), Wire Cutters (FDA Code: HXZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Wire Holding Forceps (FDA Code: HYA), Biopsy Forceps Cover (FDA Code: FFF), Disconnect Forceps (FDA Code: FJR), ...
Armasa Traders deals with forceps. Our products include biopsy forceps covers, disconnect forceps, forceps and wire holding forceps. more...
Spectrum Surgical Supplies | Address: 4/33 Ch. Fazal Din St., Ahmed Pura, Sialkot 51310, Pakistan
Phone: +92-(703)-6283591
FDA Registration: 3005374323
Products: ENT Nasal Gouge (FDA Code: KAQ), Soft Ear Speculum (FDA Code: EPY), Ear Speculum (FDA Code: EPY), ENT Elevator (FDA Code: KAD), Microsurgical Ear Hook (FDA Code: JYL), Nasal Knife (FDA Code: KAS), ...
Spectrum Surgical Supplies offers medical surgical instruments. Our product line comprises of ENT mirror, ENT elevator, forceps, amputation knife, ENT nasal gouge and general use surgical curettes. We more...
Phone: +92-(703)-6283591
FDA Registration: 3005374323
Products: ENT Nasal Gouge (FDA Code: KAQ), Soft Ear Speculum (FDA Code: EPY), Ear Speculum (FDA Code: EPY), ENT Elevator (FDA Code: KAD), Microsurgical Ear Hook (FDA Code: JYL), Nasal Knife (FDA Code: KAS), ...
Spectrum Surgical Supplies offers medical surgical instruments. Our product line comprises of ENT mirror, ENT elevator, forceps, amputation knife, ENT nasal gouge and general use surgical curettes. We more...
Mian Shahid Corp. | Address: St #1 Chowk Shahab Pura, Muzaffar Pur, Sialkot, PK-PB, Pakistan
www.mianshahid.com | Send Inquiry | Phone: +92-(523)-562-641
FDA Registration: 3002834291
Products: Bone Mallets (FDA Code: HXL), Amputation Knife (FDA Code: GDN), Chisel/Osteotome (FDA Code: KDG), Bedpan (FDA Code: FOB), Clip Rack (FDA Code: HBR), Clip Removal Instrument (FDA Code: HBQ), ...
Mian Shahid Corp. is a manufacturer and supplier of dental and surgical instruments. Our surgical products include intestinal clamps, artery forceps, retractros, kidney clamps and forceps, mallets & n more...
www.mianshahid.com | Send Inquiry | Phone: +92-(523)-562-641
FDA Registration: 3002834291
Products: Bone Mallets (FDA Code: HXL), Amputation Knife (FDA Code: GDN), Chisel/Osteotome (FDA Code: KDG), Bedpan (FDA Code: FOB), Clip Rack (FDA Code: HBR), Clip Removal Instrument (FDA Code: HBQ), ...
Mian Shahid Corp. is a manufacturer and supplier of dental and surgical instruments. Our surgical products include intestinal clamps, artery forceps, retractros, kidney clamps and forceps, mallets & n more...
Micro Engineering Co. | Address: Muzaffar Pur, Ugoki Road, Sialkot, PK-PB 51310, Pakistan
www.micromanicure.com | Send Inquiry | Phone: +92-(52)-3563928
Products: General & Plastic Surgery Mirror (FDA Code: FTX), General Surgical Scissors (FDA Code: LRW), Surgical Cutter (FDA Code: FZT), Tweezer Type High-Frequency Epilator (FDA Code: KCX), Manual Cast Application and Removal Instrument (FDA Code: LGG), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Micro Engineering Co. is a manufacturer of surgical, dental and personal care instruments. Our surgical products include diagnostic, scissors, dissecting & tissue forceps, ligature forceps, suture, re more...
www.micromanicure.com | Send Inquiry | Phone: +92-(52)-3563928
Products: General & Plastic Surgery Mirror (FDA Code: FTX), General Surgical Scissors (FDA Code: LRW), Surgical Cutter (FDA Code: FZT), Tweezer Type High-Frequency Epilator (FDA Code: KCX), Manual Cast Application and Removal Instrument (FDA Code: LGG), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Micro Engineering Co. is a manufacturer of surgical, dental and personal care instruments. Our surgical products include diagnostic, scissors, dissecting & tissue forceps, ligature forceps, suture, re more...
Biopsy Fine Cut Instruments | Address: Old Bus Stand Near Municipal Corporation, Rehman Street, Teh. Pasrur, Sialkot, PK-PB 51310, Pakistan
FDA Registration: 3006891796
Products: Forceps (FDA Code: HTD), Rigid Laryngoscope (FDA Code: CCW), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Metal Vaginal Speculum (FDA Code: HDF), Surgical Orthopedic Scissors (FDA Code: HRR), ENT Esophageal Dilator (FDA Code: KCF), ...
Biopsy Fine Cut Instruments specializes in surgical instruments. more...
FDA Registration: 3006891796
Products: Forceps (FDA Code: HTD), Rigid Laryngoscope (FDA Code: CCW), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Metal Vaginal Speculum (FDA Code: HDF), Surgical Orthopedic Scissors (FDA Code: HRR), ENT Esophageal Dilator (FDA Code: KCF), ...
Biopsy Fine Cut Instruments specializes in surgical instruments. more...
Nadir & Co. | Address: Nadir & Co, Ugoki Road, Opp Small, Industrial Estate, Sialkot, Punjab 51340, Pakistan
www.nadirco.com | Send Inquiry | Phone: +92-(52)-3556741
FDA Registration: 3005897698 Quality: ISO 9001 : 2003 and ISO 13485 : 2003,CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Nadir & Co. manufactures surgical and diagnostic instruments. Our products line comprises of surgical instruments, dental instruments, orthodontic instruments, laboratory instruments and impression tr more...
www.nadirco.com | Send Inquiry | Phone: +92-(52)-3556741
FDA Registration: 3005897698 Quality: ISO 9001 : 2003 and ISO 13485 : 2003,CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Nadir & Co. manufactures surgical and diagnostic instruments. Our products line comprises of surgical instruments, dental instruments, orthodontic instruments, laboratory instruments and impression tr more...
Falcon Surgical Co (Pvt) Ltd. | Address: Wazirabad Rd., P.O. Box 134, Near Village Golophala Ugoki, Sialkot, Punjab, Pakistan
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
Dr. Frigz International (Pvt) Ltd. | Address: Airport Rd., Gohadpur, Sialkot, Punjab 51360, Pakistan
Phone: +92-(524)-262705
FDA Registration: 3003644849
Products: Forceps (FDA Code: HTD), Nasal Scissors Straight (FDA Code: KBD), Tonsil Dissector (FDA Code: KBM), Nasal Scissors (FDA Code: KBD), General Surgical Scissors (FDA Code: LRW), Penile Clamp (FDA Code: FHA), ...
Dr. Frigz International (Pvt) Ltd. is a manufacturer of surgical and dental instruments. We offer bone curettes, mouth mirrors, needle holders, tongue depressors and scalpel handles. more...
Phone: +92-(524)-262705
FDA Registration: 3003644849
Products: Forceps (FDA Code: HTD), Nasal Scissors Straight (FDA Code: KBD), Tonsil Dissector (FDA Code: KBM), Nasal Scissors (FDA Code: KBD), General Surgical Scissors (FDA Code: LRW), Penile Clamp (FDA Code: FHA), ...
Dr. Frigz International (Pvt) Ltd. is a manufacturer of surgical and dental instruments. We offer bone curettes, mouth mirrors, needle holders, tongue depressors and scalpel handles. more...
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FDA Code / Regulation: HXZ / 888.4540
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 888.9.
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