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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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- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 1720747
- DUNS Number
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Catalogue (14345)
Page 44 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Schrom Osteotome | 350-835RTB | FDA UDI | Class I | Active |
| Daniel Gubisch Rib Raspatory | 430-378 | FDA UDI | Class I | Active |
| Micro Friedman Rongeur | 1106-079 | FDA UDI | Class I | Active |
| Lebsche Sternum Chisel | 430-401 | FDA UDI | Class I | Active |
| Bowman Lacrimal Probe | 16-2587 | FDA UDI | Class I | Active |
| Liposuction Cannula | 201-290 | FDA UDI | Class I | Unknown |
| Titanium Debakey Neonatal Clamp | 2605-158A | FDA UDI | Class II | Unknown |
| Best Intestinal Clamp | 10-0571 | FDA UDI | Class I | Active |
| Egress Cannula | SC94-0321 | FDA UDI | Class I | Active |
| Iris Retractor | 12-4800 | FDA UDI | Class I | Active |
| Jacquette Scaler | 1102-SCJ2S-3SL | FDA UDI | Class I | Active |
| Forceps | 2200-210 | FDA UDI | Class I | Active |
| Lighted Smith Nerve Retractor | 412-723 | FDA UDI | Class I | Active |
| Heartline Atrial Retractor Rod Holder Introducer | 2800-5198 | FDA UDI | Class I | Active |
| Reynolds Tenotomy Scissors | 2400-831D | FDA UDI | Class I | Active |
| Gallaher Bone Raspatory | 77-0450 | FDA UDI | Class I | Active |
| Sontec Adson Forceps | 136-656 | FDA UDI | Class I | Active |
| Derf Needle Holder | 132-634Q | FDA UDI | Class I | Active |
| Black Farrior Ear Specula | 465-276 | FDA UDI | Class I | Active |
| Tear Drop Spinal Curette | 320-962 | FDA UDI | Class I | Active |
| Rhoton Pick | 413-012 | FDA UDI | Class I | Active |
| Straight Tip | 16-3101A | FDA UDI | Class I | Active |
| Diethrich Scissors | 2400-125 | FDA UDI | Class I | Active |
| Lempert Rongeur | 315-544Q | FDA UDI | Class I | Active |
| Micro Needle Holder | 2602-302 | FDA UDI | Class I | Active |
| Sontec Neuro Suction | 412-858 | FDA UDI | Class II | Unknown |
| Debakey Morris Vascular Clamp | 2100-659 | FDA UDI | Class II | Unknown |
| Debakey Neonatal Clamp | 2100-579D | FDA UDI | Class II | Unknown |
| Resano Brown Forceps | 2200-361 | FDA UDI | Class I | Active |
| Dental Elevator | 1103-389-7V | FDA UDI | Class I | Active |
| Lister Bandage Scissors | 1200-686 | FDA UDI | Class I | Active |
| Herbst-Doolen Wire Passer | 1103-841 | FDA UDI | Class I | Active |
| Bone Reduction Clamp | 1103-039S | FDA UDI | Class I | Active |
| Sontec Dissector | 412-546 | FDA UDI | Class I | Active |
| Frazier Suction Tube | 412-680I | FDA UDI | Class II | Active |
| Micasept Babcock Clamp | 20919-12-005 | FDA UDI | Class II | Active |
| Gradle Scissors | 199-515 | FDA UDI | Class I | Active |
| Knolle Iris Hook | 12-5400 | FDA UDI | Class I | Active |
| Garrett Vascular Dilator | 2700-004P | FDA UDI | Class II | Unknown |
| Cooley Multi Purpose Clamp | 2100-232 | FDA UDI | Class II | Unknown |
| Debakey Forceps | 2100-828 | FDA UDI | Class I | Unknown |
| Aebli Corneal Scissors | 13-7030 | FDA UDI | Class I | Active |
| Wellace-Stifle Retractor | 1100-635C | FDA UDI | Class I | Active |
| Depth Gauge | 355-170 | FDA UDI | Class I | Active |
| Yasargil Bayonet Scissors | 400-288 | FDA UDI | Class I | Active |
| Hirschfield Periosteal Elevator | 1102-CPLH20 | FDA UDI | Class I | Active |
| McPHERSON-WESTCOTT CONJUNCTIVAL SCISSORS | 13-3300 | FDA UDI | Class I | Active |
| New Orleans Wire Twister | 2300-602 | FDA UDI | Class I | Active |
| Debakey Neonatal Clamp | 2100-589A | FDA UDI | Class II | Unknown |
| Classic Dental Elevator Set | 1103-399-SET | FDA UDI | Class I | Active |
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