Junior Tongue Depressor Suppliers
Limit companies to: Worldwide USA
Dimeda Instrumente Gmbh | Address: Gansacker 54+58, Tuttlingen 78532, Germany 
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Obstetrical Forceps (FDA Code: HDA), Aneurysm Clip Applier (FDA Code: HCI), Micro Ophthalmic Scissors, Adjustable Frequency Tuning Fork, Aluminium Tuning Fork, Ophthalmic Suture Scissors (FDA Code: HNF), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Obstetrical Forceps (FDA Code: HDA), Aneurysm Clip Applier (FDA Code: HCI), Micro Ophthalmic Scissors, Adjustable Frequency Tuning Fork, Aluminium Tuning Fork, Ophthalmic Suture Scissors (FDA Code: HNF), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
Idea-Instrumentefabrik Berchtold & Co. GmbH | Address: Weimarstr 13-15, Tuttlingen 78532, Germany
Phone: +49-(7461)-2345
FDA Registration: 8010153 Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Double Prong Skin Hooks, Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Obstetrical Forceps (FDA Code: HDA), Gillies Skin Hook, ...
Idea-Instrumentefabrik Berchtold & Co. GmbH specializes in the manufacture and export of medical & dental instruments. Our products include dental impression trays, hemostats, uterine dilators, dental more...
Phone: +49-(7461)-2345
FDA Registration: 8010153 Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Double Prong Skin Hooks, Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Obstetrical Forceps (FDA Code: HDA), Gillies Skin Hook, ...
Idea-Instrumentefabrik Berchtold & Co. GmbH specializes in the manufacture and export of medical & dental instruments. Our products include dental impression trays, hemostats, uterine dilators, dental more...
Medicon eG | Address: Postfach 44 55, Tuttlingen D-78509, Germany
www.medicon.de | Send Inquiry | Phone: +49-(0)-7462/20-09-0
FDA Registration: 8010099 Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Curettes, Forceps (FDA Code: HTD), Scissors, Titanium Plating Systems, Pituitary Scoops, ...
Medicon eG specializes in the production of surgical tools. We offer a wide range of instruments for anaesthesia. Our modified magill forceps are characterised by atraumatic jaws that render safe and more...
www.medicon.de | Send Inquiry | Phone: +49-(0)-7462/20-09-0
FDA Registration: 8010099 Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Curettes, Forceps (FDA Code: HTD), Scissors, Titanium Plating Systems, Pituitary Scoops, ...
Medicon eG specializes in the production of surgical tools. We offer a wide range of instruments for anaesthesia. Our modified magill forceps are characterised by atraumatic jaws that render safe and more...
A. Schweickhardt GmbH & Co. KG | Address: Bahnhofstraße 80, Tuttlingen D-78532, Germany
www.schwert.com | Send Inquiry | Phone: +49-(7461)-9297-0
FDA Registration: 8010159
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Nasal Punch (FDA Code: KAY), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Hammer (FDA Code: FZY), Surgical Knife (FDA Code: EMF), ...
A. Schweickhardt GmbH & Co. KG is a developer, manufacturer and supplier of medical & dental products. We are specialized in the production of forceps, pliers, hand instruments and many further instru more...
www.schwert.com | Send Inquiry | Phone: +49-(7461)-9297-0
FDA Registration: 8010159
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Nasal Punch (FDA Code: KAY), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Hammer (FDA Code: FZY), Surgical Knife (FDA Code: EMF), ...
A. Schweickhardt GmbH & Co. KG is a developer, manufacturer and supplier of medical & dental products. We are specialized in the production of forceps, pliers, hand instruments and many further instru more...
Dufner Instrumente GmbH | Address: Föhrenstraße 9, Tuttlingen 78532, Germany
www.dufner-tuttlingen.de | Send Inquiry | Phone: +49-(7461)-3697
FDA Registration: 9612278
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Dufner Instrumente GmbH is a manufacturer of surgical instruments. We manufacture various laparoscopy products including grasping forceps, scissors, biopsy forceps, needle holders, endoscopes, light g more...
www.dufner-tuttlingen.de | Send Inquiry | Phone: +49-(7461)-3697
FDA Registration: 9612278
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Dufner Instrumente GmbH is a manufacturer of surgical instruments. We manufacture various laparoscopy products including grasping forceps, scissors, biopsy forceps, needle holders, endoscopes, light g more...
A.Handte Medizintechnik Gmbh & Co. Kg | Address: Ehrenbergstrasse 39, Tuttlingen D-78532, Germany
Phone: +49-(074)-61-15337
FDA Registration: 8010155
Products: Ear Curette (FDA Code: JYG), Ear Spoon (FDA Code: JZE), ENT Elevator (FDA Code: KAD), Mastoid Chisel (FDA Code: JYD), Mastoid Gauge (FDA Code: JYI), Middle Ear Chisel (FDA Code: JYE), ...
A.Handte Medizintechnik Gmbh & Co. Kg offers cardio vascular instruments. more...
Phone: +49-(074)-61-15337
FDA Registration: 8010155
Products: Ear Curette (FDA Code: JYG), Ear Spoon (FDA Code: JZE), ENT Elevator (FDA Code: KAD), Mastoid Chisel (FDA Code: JYD), Mastoid Gauge (FDA Code: JYI), Middle Ear Chisel (FDA Code: JYE), ...
A.Handte Medizintechnik Gmbh & Co. Kg offers cardio vascular instruments. more...
Willy Storz Gmbh | Address: Liptinger Str. 112, Tuttlingen D-78532, Germany
Phone: +49-(7461)-2961
FDA Registration: 9611262
Products: Tongue Depressors (FDA Code: FMA), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), ...
Willy Storz Gmbh offers adult tongue depressor, general & plastic surgery surgical elevator, rasp & spatula, infant tongue depressor, non-surgical tongue depressor, surgical retractor systems, tongue more...
Phone: +49-(7461)-2961
FDA Registration: 9611262
Products: Tongue Depressors (FDA Code: FMA), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), ...
Willy Storz Gmbh offers adult tongue depressor, general & plastic surgery surgical elevator, rasp & spatula, infant tongue depressor, non-surgical tongue depressor, surgical retractor systems, tongue more...
Normed Gmbh | Address: Ulrichstr. 7, Tuttlingen 78532, Germany
www.normed-online.com | Send Inquiry | Phone: +49-(7461)-9343-0
Quality: CE mark 0123 ISO 13485 : 2003 and DIN EN 46001 Certified
Products: Stainless Steel Surgical Wire, Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Wire (FDA Code: LRN), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General & Plastic Surgery Surgical Gouge (FDA Code: GDH), ...
Normed Gmbh is a manufacturer of medical devices. We offer orthopedic, hand, neuro, foot or ankle, cranio-maxillo-facial surgery and ascension products. Our external fixator modular systems cover all more...
www.normed-online.com | Send Inquiry | Phone: +49-(7461)-9343-0
Quality: CE mark 0123 ISO 13485 : 2003 and DIN EN 46001 Certified
Products: Stainless Steel Surgical Wire, Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Wire (FDA Code: LRN), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General & Plastic Surgery Surgical Gouge (FDA Code: GDH), ...
Normed Gmbh is a manufacturer of medical devices. We offer orthopedic, hand, neuro, foot or ankle, cranio-maxillo-facial surgery and ascension products. Our external fixator modular systems cover all more...
Aesculap Ag | Address: 1120, Tuttlingen, Donau D-78532, Germany
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
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), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
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), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
Gustav Fleischer Jr. Holzwarenfabrik | Address: 41, Brueckenweg, Wermelskirchen 42929, Germany
Phone: +49-(2196)-2621
Employee Count: ~20
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Plain Tongue Depressor, Angled Tongue Depressor, Non-Surgical Tongue Depressor (FDA Code: FMA), ...
Gustav Fleischer Jr. Holzwarenfabrik provides tongue depressors. more...
Phone: +49-(2196)-2621
Employee Count: ~20
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Plain Tongue Depressor, Angled Tongue Depressor, Non-Surgical Tongue Depressor (FDA Code: FMA), ...
Gustav Fleischer Jr. Holzwarenfabrik provides tongue depressors. more...
Allsurg Medizintechnik UG | Address: Bachstr 8,, County Is Tuttlingen, Wurmlingen 78573, Germany
Phone: +49-(7461)-9107211
Products: Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Metal Vaginal Speculum (FDA Code: HDF), Curettes (FDA Code: HTF), ENT Mirror (FDA Code: KAI), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Phone: +49-(7461)-9107211
Products: Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Metal Vaginal Speculum (FDA Code: HDF), Curettes (FDA Code: HTF), ENT Mirror (FDA Code: KAI), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Gimmi GmbH | Address: Carl-Zeiss-Strasse 6, Tuttlingen, Baden-Wuerttemberg D-78532, Germany
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Yasargil Aneurysm Clips, Cystoscopes, Surgical Instrument (Miscellaneous Medical), Laparoscopy, Laparoscopes, Hysteroscope Diagnosing System, Electrosurgical Accessories, Bipolar Coagulation Forceps, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Yasargil Aneurysm Clips, Cystoscopes, Surgical Instrument (Miscellaneous Medical), Laparoscopy, Laparoscopes, Hysteroscope Diagnosing System, Electrosurgical Accessories, Bipolar Coagulation Forceps, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
CM Instrumente GmbH | Address: Im Gänsäcker 56, Tuttlingen, Deutschland 78532, Germany
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
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), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
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), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
Tekno-medical Optik-Chirurgie GmbH & Co KG. | Address: Sattlerstrasse 11, Tuttlingen D-78532, Germany
www.tekno-medical.com | Send Inquiry | Phone: +49-(7461)-1701-0
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Kerrison Punches, Laryngeal Mirrors, Nasal & Ear Specula, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, ...
Tekno-medical Optik-Chirurgie GmbH & Co KG. specializes in surgery, endoscopy, ENT, H-F surgery, and dental instruments. We also focus on the supply of different medical articles. Our product catalogu more...
www.tekno-medical.com | Send Inquiry | Phone: +49-(7461)-1701-0
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Kerrison Punches, Laryngeal Mirrors, Nasal & Ear Specula, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, ...
Tekno-medical Optik-Chirurgie GmbH & Co KG. specializes in surgery, endoscopy, ENT, H-F surgery, and dental instruments. We also focus on the supply of different medical articles. Our product catalogu more...
Etablissements Boutmy S.A. | Address: Saint Aubin Le Monial, Rue Le Pavillon, Bourbon L Archambault 03160, France
Phone: +33-(70)-67-0451
FDA Registration: 9680837
Products: Nasal Rasps (FDA Code: KBA), Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, ...
Etablissements Boutmy S.A. specializes in offering disposable and implantable products. Our products include obstetric and gynecologic general manual instruments, tongue depressor, various needle hold more...
Phone: +33-(70)-67-0451
FDA Registration: 9680837
Products: Nasal Rasps (FDA Code: KBA), Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, ...
Etablissements Boutmy S.A. specializes in offering disposable and implantable products. Our products include obstetric and gynecologic general manual instruments, tongue depressor, various needle hold more...
Allegiance Healthcare Corp. | Address: Zona Franca Las Americas, Autlas Americas Km 22 1-2 Sur, Santo Domingo, Dominican Republic
Phone: 847-473-1500
FDA Registration: 9680904
Products: Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Amniotic Fluid Sampler (FDA Code: HIO), Biopsy Needle Kit (FDA Code: FCG), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Phone: 847-473-1500
FDA Registration: 9680904
Products: Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Amniotic Fluid Sampler (FDA Code: HIO), Biopsy Needle Kit (FDA Code: FCG), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Jiaxin Medical Material Co., Ltd. | Address: No.8 Redian Road, Anqing 246001, China 
www.jiaxinco.com | Send Inquiry | Phone: +86-(556)-5564068
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Sterile Absorbent Tipped Applicator (FDA Code: KXG), ...
Jiaxin Medical Material Co., Ltd. manufactures medical cotton swab and spatula. Our products include 8" skin scrub cotton stick bamboo stick, 6" common cotton stick bamboo stick, 6" mouse cotton stick more...
www.jiaxinco.com | Send Inquiry | Phone: +86-(556)-5564068
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Sterile Absorbent Tipped Applicator (FDA Code: KXG), ...
Jiaxin Medical Material Co., Ltd. manufactures medical cotton swab and spatula. Our products include 8" skin scrub cotton stick bamboo stick, 6" common cotton stick bamboo stick, 6" mouse cotton stick more...
Fang Lin Wooden Products Co., Ltd. | Address: Shih Chiao Tzu Chen, Benxi Economic And Technical Developing Zone, Benxi, Liaoning 117004, China
www.flh.com.tw | Phone: +86-(414)-5851608
Year Established: 1971 Employee Count: ~150 Quality: ISO 9001, CE, FDA, EN46002 Certified
Products: Tongue Depressors (FDA Code: FMA), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), ...
Fang Lin Wooden Products Co., Ltd. specializes in the manufacture & export of wooden tongue depressors, cervical scrapers, and cotton applicators. Our wooden tongue scrapers are available in 205 x 18 more...
www.flh.com.tw | Phone: +86-(414)-5851608
Year Established: 1971 Employee Count: ~150 Quality: ISO 9001, CE, FDA, EN46002 Certified
Products: Tongue Depressors (FDA Code: FMA), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), ...
Fang Lin Wooden Products Co., Ltd. specializes in the manufacture & export of wooden tongue depressors, cervical scrapers, and cotton applicators. Our wooden tongue scrapers are available in 205 x 18 more...
China Jilin Provincial Medicines & Health Product | Address: 29 Jian She St., Changchun, China
Phone: +86-(431)-85689
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Plain Tongue Depressor, Angled Tongue Depressor, Non-Surgical Tongue Depressor (FDA Code: FMA), ...
China Jilin Provincial Medicines & Health Product provides various types of tongue depressors and non-surgical products. more...
Phone: +86-(431)-85689
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Plain Tongue Depressor, Angled Tongue Depressor, Non-Surgical Tongue Depressor (FDA Code: FMA), ...
China Jilin Provincial Medicines & Health Product provides various types of tongue depressors and non-surgical products. more...
Changchun Kangda Medical Supply Co., Ltd. | Address: 4 Huo Ju Rd., Changchun, China
Phone: +86-(431)-51797
Products: Disposable Irrigating Syringe, Enteral Irrigation Kit w/Piston Syringe, Adult-Pediatric Volumetric Infusion Pumps, Piston Syringe (FDA Code: FMF), Non Dental Irrigating Syringe (FDA Code: KYZ), Peristaltic Infusion Pump (FDA Code: FRN), ...
Changchun Kangda Medical Supply Co., Ltd. specializes in offering infusion pumps. Our products include irrigation syringes, I.V. administration sets, tongue depressors, cervical scrapers, transfusion more...
Phone: +86-(431)-51797
Products: Disposable Irrigating Syringe, Enteral Irrigation Kit w/Piston Syringe, Adult-Pediatric Volumetric Infusion Pumps, Piston Syringe (FDA Code: FMF), Non Dental Irrigating Syringe (FDA Code: KYZ), Peristaltic Infusion Pump (FDA Code: FRN), ...
Changchun Kangda Medical Supply Co., Ltd. specializes in offering infusion pumps. Our products include irrigation syringes, I.V. administration sets, tongue depressors, cervical scrapers, transfusion more...
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FDA Code / Regulation: FMA / 880.6230
A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
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 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
