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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 43 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stille Osteotome | 330-730 | FDA UDI | Class I | Active |
| Halstead Mosquito Forceps | 115-407 | FDA UDI | Class I | Active |
| Kratz Barraquer Wire Speculum | 10-1050 | FDA UDI | Class I | Active |
| Debakey Neonatal Clamp | 2100-592A | FDA UDI | Class II | Unknown |
| Diethrich Scissors | 2400-745C | FDA UDI | Class I | Active |
| Reynolds Tenotomy Scissors | 2405-329D | FDA UDI | Class I | Active |
| Cooley Bulldog Clamp | 2100-435 | FDA UDI | Class II | Active |
| Troutman Alpha-Chymotrypsin Cannula | 16-4100 | FDA UDI | Class I | Active |
| Paul Skin Rake Retractor | 199-490 | FDA UDI | Class I | Active |
| Ribbon Retractor | 207-463 | FDA UDI | Class I | Active |
| Gills-Welsh Asprirating Cannula | 16-5880 | FDA UDI | Class I | Active |
| Stevens Tenotomy Classic Scissors | 13-8805 | FDA UDI | Class I | Active |
| Unique Periosteal Elevator | 1103-326 | FDA UDI | Class I | Unknown |
| O-Ring Hemorrhoid Band Cutter | 508-556 | FDA UDI | Class I | Active |
| Air Injection Cannula | 16-3800 | FDA UDI | Class I | Active |
| Finesse Scissors | 2400-551 | FDA UDI | Class I | Active |
| Iris Dressing Forceps | 14-4410 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 404-337B | FDA UDI | Class I | Active |
| Debakey Scissors | 2400-085 | FDA UDI | Class I | Active |
| Finochietto Spreader Retractor | 2500-095B | FDA UDI | Class I | Active |
| Wire End Pin Cutter | 1103-108 | FDA UDI | Class I | Active |
| Swedish Style Needle Holder | 2300-670 | FDA UDI | Class I | Active |
| Maccollum-Dingman Breast Dissector | 475-630 | FDA UDI | Class I | Active |
| Iris Scissors | 13-7510 | FDA UDI | Class I | Active |
| Kerrison Universal Rotating Rongeur | 404-6083E | FDA UDI | Class I | Active |
| Disposable Footswitch Suction Coagulator | SCF10 | FDA UDI | Class II | Active |
| Easy Change Irrigation Aspiration System Tip | T16-3101A | FDA UDI | Class I | Active |
| Fukushima Suction Tube | 180-408 | FDA UDI | Class II | Unknown |
| Micasept Debakey Peripheral Atraumatic Vascular Clamp | 20919-08-014 | FDA UDI | Class II | Unknown |
| Tissue Forceps | 1100-861 | FDA UDI | Class I | Active |
| Stevens Tenotomy Scissors | 1200-702 | FDA UDI | Class I | Active |
| Takahashi Rongeur | 404-7875 | FDA UDI | Class I | Active |
| Biopsy Grasping Forceps | 1271-101R | FDA UDI | Class I | Active |
| Micro Vein Clamp Pair | 2100-ABB-1V | FDA UDI | Class II | Unknown |
| Debakey Vascular Clamp | 2100-608 | FDA UDI | Class II | Unknown |
| Micro Biopsy Forceps | 469-084Q | FDA UDI | Class I | Active |
| Quisling Intranasal Hammer | 475-757 | FDA UDI | Class I | Active |
| Grasping Forceps | 2901-237 | FDA UDI | Class II | Active |
| V.a.t.s. Sliding Shaft Satinsky Clamp | 2100-786 | FDA UDI | Class II | Active |
| Graefe Fixation Forceps | 14-5120 | FDA UDI | Class I | Active |
| Yasargil Raspatory | 400-423 | FDA UDI | Class I | Active |
| Sontec Bone Hook | 320-935 | FDA UDI | Class I | Active |
| Castroviejo Needle Holder | 15-1911 | FDA UDI | Class I | Active |
| Black Bipolar Bayonet Forceps | 2700-854NS | FDA UDI | Class II | Unknown |
| Introducer Shaft | 2800-516 | FDA UDI | Class I | Unknown |
| Fasanella Lacrimal Cannula | 16-3350 | FDA UDI | Class I | Active |
| Jewelers Precision Forceps | 2200-007 | FDA UDI | Class I | Active |
| Black Kilner Scissors | 2400-889 | FDA UDI | Class I | Active |
| Piffard Dermal Curette | 199-201 | FDA UDI | Class I | Active |
| St Marks Hand Retractor | 508-327L | FDA UDI | Class I | Active |
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