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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
- —
- FDA FEI Number
- 1720747
- DUNS Number
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Catalogue (14345)
Page 50 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Minature Finochietto Retractor | 2605-140 | FDA UDI | Class I | Active |
| Vannas Scissor | 13-5348F | FDA UDI | Class I | Active |
| Pashley Laryngoscope | 1412-562 | FDA UDI | Class I | Active |
| Kalt Needle Holder | 15-2100 | FDA UDI | Class I | Active |
| Finger Goniometer | 350-915 | FDA UDI | Class I | Active |
| Stevens Tenotomy Scissors | 1200-928 | FDA UDI | Class I | Active |
| Castroviejo Scissors | 2400-619E | FDA UDI | Class I | Active |
| Blessings Scissors | 05-1600 | FDA UDI | Class I | Active |
| Titanium Beck Aortic Clamp | 2605-130 | FDA UDI | Class II | Active |
| Micro Artery Clamp Pair | 2100-RD-DA | FDA UDI | Class II | Active |
| V.a.t.s Duval Clamp | 2100-825A | FDA UDI | Class II | Unknown |
| Weldon Mini Bulldog Clamp | 2100-450 | FDA UDI | Class II | Active |
| Sontec Kerrison Rongeur | 404-539Q | FDA UDI | Class I | Active |
| Ring Cannula | 16-3990 | FDA UDI | Class I | Active |
| Euphrate-Pasque Needle Holder | 2300-662Q | FDA UDI | Class I | Active |
| Nasal/Tendon Knife | 1271-181 | FDA UDI | Class I | Active |
| Debakey Tangential Occlusion Clamp | 2100-722 | FDA UDI | Class II | Unknown |
| Heartline Atrial Ball Lock | 2800-5200 | FDA UDI | Class I | Active |
| Sontec Barraquer Needle Holder | T15-4130 | FDA UDI | Class I | Active |
| Rhoton Raspatory | 413-002S | FDA UDI | Class I | Active |
| Micasept Atraumatic Tissue Grasper | 20919-06-005 | FDA UDI | Class II | Unknown |
| Arkansas Hard Sharpener | 1100-5821 | FDA UDI | Class I | Unknown |
| Tissue Forceps | 1100-859 | FDA UDI | Class I | Active |
| Gans Severin Cycled Cannula | 16-6086 | FDA UDI | Class I | Active |
| Deaver Retractor | 207-426 | FDA UDI | Class I | Active |
| Sontec Atrial Retractor Rake | 2500-4734R | FDA UDI | Class I | Active |
| Cottle Dorsal Scissors | 1200-806 | FDA UDI | Class I | Active |
| Pashley Hook | 1197-673 | FDA UDI | Class I | Active |
| Verbrugge Bone Clamp | 1103-077 | FDA UDI | Class I | Active |
| Transsphenoidal Nasal Retractor | 465-330 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 404-474B | FDA UDI | Class I | Active |
| Compressor | 416-615 | FDA UDI | Class I | Active |
| Finochietto Retractor | 1101-500 | FDA UDI | Class I | Active |
| Tube Shaft Insulated | 2901-106 | FDA UDI | Class II | Unknown |
| Titanium Debakey Neonatal Clamp | 2605-153B | FDA UDI | Class II | Unknown |
| Sontec Knife Handle | 1100-8681 | FDA UDI | Class I | Active |
| Strabismus Scissors | 13-9315 | FDA UDI | Class I | Active |
| Heartline Scissors | 2800-245S | FDA UDI | Class II | Unknown |
| Halstead Mosquito Forceps | 115-412Q | FDA UDI | Class I | Active |
| Bailey Hemostatic Forceps | 2200-523 | FDA UDI | Class I | Active |
| Mitchell Aortic Valve Dilator | 2700-212 | FDA UDI | Class II | Unknown |
| Universal Extracting Forceps | 1103-356C | FDA UDI | Class I | Active |
| Church Scissors | 440-305 | FDA UDI | Class I | Active |
| Sedillot Elevator | 335-226 | FDA UDI | Class I | Active |
| Hirschman Anascope | 508-360 | FDA UDI | Class I | Active |
| Jacobson Needle Holder | 2300-168 | FDA UDI | Class I | Active |
| Mathieu Needle Holder | 1100-101 | FDA UDI | Class I | Active |
| Cleveland Rongeur | 315-527 | FDA UDI | Class I | Active |
| Glasser Micro Needle Holder | 2300-0500 | FDA UDI | Class I | Active |
| Lasik Flap Spatula | 12-2860 | FDA UDI | Class I | Active |
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