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Sign in to claim this brandSONTEC INSTRUMENTS, INC.
US
Last updated September 17, 2026
What SONTEC INSTRUMENTS, INC. makes
SONTEC Instruments, Inc. manufactures reusable surgical instruments, including needle holders, general-purpose scissors, soft-tissue manipulation forceps (tweezers-like and scissors-like variants), orthopaedic rongeurs, bone curettes, retractors, and ophthalmic forceps. Their product line also includes specialized tools like the Lester Lens Pusher, Jacobson Scissors, and Desmarres Lid Retractor, as well as urological and corneal forceps.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sontec Instruments, Inc. manufacture?
Sontec Instruments, Inc. specializes in reusable surgical instruments. Their product line includes general-purpose tools like suturing needle holders, surgical scissors, and retractors, as well as specialized variants such as ophthalmic forceps (e.g., Lester Lens Pusher, Girard Corneoscleral Forceps) and orthopaedic tools (e.g., rongeurs, bone curettes). These instruments are designed for precision tasks in various surgical specialties, including ophthalmology, orthopaedics, and general surgery.
Where is Sontec Instruments, Inc. based, and how does that affect its devices?
Sontec Instruments, Inc. is based in the United States. This means their devices are subject to U.S. regulatory requirements, including classification under the FDA’s system. The company’s U.S. location also influences compliance pathways, such as registration with the FDA and potential participation in U.S.-specific registries like the Unique Device Identifier (UDI) database.
Which regulatory registries list Sontec Instruments, Inc.’s devices?
Sontec Instruments, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized registry that assigns unique identifiers to medical devices to improve tracking, transparency, and compliance with U.S. regulatory requirements. This listing helps healthcare providers and regulators verify device details, such as manufacturer information and classification.
How are Sontec Instruments, Inc.’s devices classified under FDA regulations?
Sontec Instruments, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls (e.g., proper labeling, manufacturing practices) without additional premarket review. Class II devices involve moderate risk and may require special controls (e.g., performance standards, postmarket surveillance) to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and surgical context (e.g., reusable ophthalmic forceps vs. general retractors).
Why do some of Sontec Instruments, Inc.’s devices appear in the UDI database while others might not?
The FDA’s UDI database includes devices that are commercially distributed in the U.S. and require a UDI label. While most of Sontec Instruments, Inc.’s reusable surgical instruments—such as their needle holders, scissors, and specialized forceps—are likely listed due to their widespread use, certain niche or legacy tools might not appear if they were discontinued, not yet marketed, or exempt from UDI requirements (e.g., devices with minimal risk or those used in limited surgical contexts). The database reflects active, distributed products subject to FDA registration.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 7248 SOUTH TUCSON WAY, CENTENNIAL, CO, 80112
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 1720747
- DUNS Number
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Catalogue (14345)
Page 52 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Debakey Morris Vascular Clamp | 2100-657 | FDA UDI | Class II | Active |
| Castroviejo Blade Breaker/Holder | 11-4700 | FDA UDI | Class I | Active |
| Garrett Vascular Dilator | 2700-050 | FDA UDI | Class II | Unknown |
| Bengolea Hemostatic Forceps | 2200-490 | FDA UDI | Class I | Active |
| Glaser Balfour Retractor | 9-5222 | FDA UDI | Class I | Active |
| Backhaus Towel Forceps | 117-500 | FDA UDI | Class I | Active |
| Liposuction Cannula | 201-034 | FDA UDI | Class II | Unknown |
| Allis Willauer Tissue Forceps | 438-414 | FDA UDI | Class I | Active |
| Guthrie Hook | 199-410 | FDA UDI | Class I | Active |
| Micasept Overholt Geissendorfer Dissector | 20920-20 | FDA UDI | Class II | Unknown |
| Dubost Thoracic Retractor Blade | 2605-4543 | FDA UDI | Class I | Active |
| Bruns Curette | 320-856 | FDA UDI | Class I | Active |
| Ragnell Scissors | 2400-377 | FDA UDI | Class I | Active |
| McPHERSON NEEDLE HOLDER | 15-1320 | FDA UDI | Class I | Active |
| Gil-Vernet Retractor | 2500-390 | FDA UDI | Class I | Active |
| Doolen Bone Clamp | 1103-842 | FDA UDI | Class I | Active |
| Minature Rod Holder | 355-221 | FDA UDI | Class I | Active |
| Cook Eye Speculum | 10-1405 | FDA UDI | Class I | Active |
| Medimark Sheet Tape | 105-622 | FDA UDI | Class I | Active |
| MIS Inner Ear Suction Dissector | 412-928 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 404-6086 | FDA UDI | Class I | Active |
| Debakey Needle Holder | 132-207 | FDA UDI | Class I | Active |
| Spinal Mallet | 330-847 | FDA UDI | Class I | Active |
| Mitchell Aortic Valve Dilator | 2700-203 | FDA UDI | Class II | Unknown |
| Bayonet Elevator | 1100-799 | FDA UDI | Class I | Active |
| Gregory Needle Holder | 2300-049 | FDA UDI | Class I | Active |
| Needle Nose Locking Pliers | 1103-137L | FDA UDI | Class I | Active |
| Kerrison Punch Rongeur | 16-2098 | FDA UDI | Class I | Active |
| Ferris Smith Arthroscopic Rongeur | 404-794LP | FDA UDI | Class I | Active |
| Kuglen Iris Hook & Lens Manipulator | T12-5810 | FDA UDI | Class I | Active |
| Mayo Hegar Needle Holder | 2300-714Q | FDA UDI | Class I | Active |
| Ramirez Endoscopic Forehead Corrugator Malleable Grasper | 2800-0004 | FDA UDI | Class I | Unknown |
| Sontec Neuro Suction | 412-854 | FDA UDI | Class II | Unknown |
| Bozemann-Finochietto Needle Holder | 2300-580 | FDA UDI | Class I | Active |
| House Wire Strut Guide | 467-560 | FDA UDI | Class I | Active |
| V.a.t.s. Mayo Hegar Needle Holder | 2300-904 | FDA UDI | Class II | Active |
| Desmarres Lid Retractor | 10-4230 | FDA UDI | Class I | Active |
| Mictec Connection Cable | 26954-30 | FDA UDI | Class II | Active |
| Rochester-Ochsner Forceps | 115-520 | FDA UDI | Class I | Active |
| Flieringa Scleral Fixation Ring Set | 10-3100-SET | FDA UDI | Class I | Active |
| Meyerhoefer-Chalazion Curette | 12-1368 | FDA UDI | Class I | Active |
| Debakey Mcaninch Forceps | 2600-5891 | FDA UDI | Class I | Active |
| Spinal Curette | 320-959 | FDA UDI | Class I | Active |
| Jacobson Needle Holder | 2600-620 | FDA UDI | Class I | Active |
| Resano Sigmoid Anastomosis Forceps | 10-0565 | FDA UDI | Class I | Active |
| Arthroscopic Hook Probe | 1271-1204U | FDA UDI | Class I | Active |
| Jackson Tracheal Retractor | 502-399 | FDA UDI | Class I | Active |
| Gelpi Retractor | 1100-631BR | FDA UDI | Class I | Active |
| McCULLOUGH RETRACTOR | 416-159 | FDA UDI | Class I | Active |
| Bruns Curette | 320-811A | FDA UDI | Class I | Active |
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