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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 48 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Micro Vein Clamp Pair | 2100-ABB-33VB | FDA UDI | Class II | Active |
| Babcock Tissue Forceps | 516-219 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 404-470Q | FDA UDI | Class I | Active |
| Medimark Sheet Tape | 105-644 | FDA UDI | Class I | Active |
| Glover Debakey Bulldog Clamp | 2100-459 | FDA UDI | Class II | Active |
| McGUIRE CORNEAL SCISSORS | 13-7012 | FDA UDI | Class I | Active |
| Debakey Tissue Forceps | 2200-1112P | FDA UDI | Class I | Active |
| Cooley Neonatal Clamp | 2100-490C | FDA UDI | Class II | Unknown |
| Collin Clamp Insert | 2901-277 | FDA UDI | Class II | Unknown |
| Power Cut Preparation Scissors Insert | 2901-303S | FDA UDI | Class II | Unknown |
| Arthroscopic Meniscotome | 1271-128U | FDA UDI | Class I | Active |
| Jacobson Needle Holder | 2300-143B | FDA UDI | Class I | Active |
| Ragnell Scissors | 2400-877 | FDA UDI | Class I | Active |
| Dorsey Grasping Forcep Insert | 2901-216L | FDA UDI | Class II | Unknown |
| Mictec Suction-Irrigation Tube | 04-11012-05 | FDA UDI | Class II | Unknown |
| Jameson Scissors | 2400-829H | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 2400-269Q | FDA UDI | Class I | Active |
| Gawsling Basket Punch | 1273-136 | FDA UDI | Class I | Active |
| Martin Cartilage Scissors | 350-861B | FDA UDI | Class I | Active |
| Smith-Petersen Gouge | 330-635 | FDA UDI | Class I | Active |
| Debakey Bahnson Aortic Clamp | 2100-6893 | FDA UDI | Class II | Active |
| Gelpi Retractor | 1100-632ABR-8 | FDA UDI | Class I | Active |
| Debakey Vascular Clamp | 2100-602 | FDA UDI | Class II | Unknown |
| Liposuction Cannula | 201-410 | FDA UDI | Class II | Unknown |
| Mayo Stille Scissors | 1200-547 | FDA UDI | Class I | Active |
| Graffe Iris Tissue Forceps | 14-1610 | FDA UDI | Class I | Active |
| Cooley Bulldog Clamp | 2100-420 | FDA UDI | Class II | Unknown |
| Gelpi Off-Set Arm Retractor | 1100-6282 | FDA UDI | Class I | Active |
| Diethrich Scissors | 2400-117 | FDA UDI | Class I | Active |
| Jacobson Neurological Scissors | 2400-6572 | FDA UDI | Class I | Active |
| Potts Smith Tissue Forceps | 2200-045 | FDA UDI | Class I | Active |
| Gelpi Retractor | 1100-628C | FDA UDI | Class I | Active |
| Sheen Fragment Retriever/Forceps | 469-035Q | FDA UDI | Class I | Active |
| Sontec Jordan Ring Retractor Frame | 516-852 | FDA UDI | Class I | Active |
| Tissue Forceps | 1100-187 | FDA UDI | Class I | Active |
| Micro Forceps | 2602-209 | FDA UDI | Class I | Active |
| Sternal Internal Mammary Artery Retractor Blade | 2605-4503 | FDA UDI | Class I | Active |
| Mckenty Elevator | 412-556 | FDA UDI | Class I | Active |
| Bayonet Circumflex Scissors | 2400-537 | FDA UDI | Class I | Active |
| Countersink Bit Cannulated | 1106-384 | FDA UDI | Class I | Active |
| Whiteside Scaler | 1102-RESCW2 | FDA UDI | Class I | Active |
| Sontec Mallet | 330-819 | FDA UDI | Class I | Active |
| Dental Elevator | 1100-586-W4V | FDA UDI | Class I | Active |
| Alligator Grasping Forceps | 1100-334 | FDA UDI | Class I | Active |
| Vasectomy Set | 516-725-SET | FDA UDI | Class I | Active |
| Abdominal Spatula | 20-0847 | FDA UDI | Class I | Active |
| Aluminum Tray | 18-2473 | FDA UDI | Class I | Active |
| Lewin Bone Holding Clamp | 1100-427Q | FDA UDI | Class I | Active |
| Loupe Light 2 | C-008.32.265 | FDA UDI | Class I | Active |
| Cooley Vascular Tissue Forceps | 442-244 | FDA UDI | Class I | Active |
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