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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 51 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Leksell Duckbill Rongeur | 315-675 | FDA UDI | Class I | Active |
| Micro Artery Clamp Pair | 2100-BB-2A | FDA UDI | Class II | Active |
| Crile-Wood Needle Holder | 132-218 | FDA UDI | Class I | Active |
| Weil Nasal Forceps | 468-548 | FDA UDI | Class I | Active |
| Cushing Forceps | 2200-384 | FDA UDI | Class I | Active |
| Needle Holder | 2600-684 | FDA UDI | Class I | Active |
| Finesse Guide Micro Forceps | 2200-199A | FDA UDI | Class I | Active |
| Forceps | 2600-426 | FDA UDI | Class I | Active |
| Alexander-Farabeuf Raspatory | 430-396 | FDA UDI | Class I | Active |
| Sontec Atrial Retractor Blade Pair | 2500-4732 | FDA UDI | Class I | Active |
| Debakey Forceps | 2200-108B | FDA UDI | Class I | Active |
| Flexible Trocar Sleeve | 15-16100-76 | FDA UDI | Class II | Active |
| Black Bipolar Hardy Bayonet Forceps | 2700-980NS | FDA UDI | Class II | Unknown |
| Ramirez Endoscopic Forehead Procerus Malleable Punch | 2800-0003 | FDA UDI | Class I | Active |
| Debakey-Diethrich Tissue Forceps | 442-240 | FDA UDI | Class I | Active |
| Ring Curette | 2900-203 | FDA UDI | Class I | Active |
| Arthroscopic Minature Hook Punch | 1271-500 | FDA UDI | Class I | Active |
| Farabeuf-Lambotte Bone Holding Clamp | 305-440 | FDA UDI | Class I | Active |
| Rod Holder | 355-2216 | FDA UDI | Class I | Active |
| Egress Cannula | SC94-0314 | FDA UDI | Class I | Active |
| Wire Cutter | 1103-112 | FDA UDI | Class I | Active |
| Semken Tissue Forceps | 136-708 | FDA UDI | Class I | Active |
| Leland Jones Clamp | 2100-638 | FDA UDI | Class I | Active |
| Freeman Kaye Saberback Scissors | 475-178 | FDA UDI | Class I | Active |
| Rankin-Kelly Forceps | 115-465 | FDA UDI | Class I | Active |
| Ryder Needle Holder | 2300-300L | FDA UDI | Class I | Active |
| Fukushima Suction Tube | 180-408 | FDA UDI | Class II | Active |
| Metzenbaum Scissors | 1200-510Q | FDA UDI | Class I | Active |
| Forceps | 2200-207B | FDA UDI | Class I | Active |
| McILWRAITH RONGEUR | 1404-855 | FDA UDI | Class I | Active |
| Titanium Cooley Neonatal Clamp | 2605-172D | FDA UDI | Class II | Unknown |
| Micasept Babcock Clamp | 20919-12 | FDA UDI | Class II | Unknown |
| Rochester-Ochsner Forceps | 115-534 | FDA UDI | Class I | Active |
| Colibri Forceps | T14-1853 | FDA UDI | Class I | Active |
| Operating Scissors | 1100-220 | FDA UDI | Class I | Active |
| Lempert Curette | 320-832T | FDA UDI | Class I | Active |
| Biospy Forceps | 1271-0151 | FDA UDI | Class I | Active |
| Micro Vein Clamp Pair | 2100-ABB-33V | FDA UDI | Class II | Unknown |
| Mathieu Needle Holder | 1100-091 | FDA UDI | Class I | Active |
| Yasargil Forceps | 2601-274 | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 2400-255 | FDA UDI | Class I | Active |
| Sontec-Cottle Osteotome | 1100-479F | FDA UDI | Class I | Active |
| Liposuction Cannula | 201-186 | FDA UDI | Class II | Unknown |
| Resano Brown Forceps | 2200-362 | FDA UDI | Class I | Active |
| Mictec Large 3 Way Tap | 04-11001-00 | FDA UDI | Class II | Active |
| McSTRATTE RADICAL PROSTATECTOMY CLAMP | 516-289 | FDA UDI | Class I | Active |
| Beyer Rongeur | 315-599 | FDA UDI | Class I | Active |
| Titanium Debakey-Diethrich Bulldog Clamp | 2600-848 | FDA UDI | Class II | Active |
| Frontal Sinus Giraffe Forceps | 468-322 | FDA UDI | Class I | Active |
| Ocular Shield | 1100-408SB | FDA UDI | Class I | Unknown |
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