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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 49 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Grasping Forceps | 1271-065R | FDA UDI | Class I | Active |
| Garrett Vascular Dilator | 2700-010P | FDA UDI | Class II | Unknown |
| Trocar | SPK03298 | FDA UDI | Class I | Active |
| McINTYRE ANTERIOR CHAMBER IRRIGATION CANNULA | 16-5470 | FDA UDI | Class I | Active |
| Gorney Kahn Scissors | 475-203 | FDA UDI | Class I | Active |
| Heartline Retractor Atrial Solid Blades | 2800-834X | FDA UDI | Class I | Active |
| Spencer Suture Scissors | 1100-296 | FDA UDI | Class I | Active |
| Gorney Scissors | 1200-495 | FDA UDI | Class I | Active |
| Babcock Tissue Forceps | 516-233B | FDA UDI | Class I | Active |
| Sontec Nasal Tip Cartilage Punch | 475-730 | FDA UDI | Class I | Active |
| Alm Retractor | 230-380 | FDA UDI | Class I | Active |
| Micasept Debakey Organ Grasping Forceps | 20919-05-060 | FDA UDI | Class II | Unknown |
| Cooley Bulldog Clamp | 2100-425 | FDA UDI | Class II | Unknown |
| Jewelers Forceps | 2200-005 | FDA UDI | Class I | Active |
| Wire Twister | 1103-149 | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 1200-905 | FDA UDI | Class I | Active |
| Micro Biopsy Alligator Forceps | 469-078 | FDA UDI | Class I | Active |
| Debakey Patent Ductus Clamp | 2100-636 | FDA UDI | Class II | Active |
| Dingman Mouth Gag Blade | 485-503 | FDA UDI | Class I | Active |
| Mayo-Lexer Scissors | 1200-543 | FDA UDI | Class I | Active |
| Laryngoscopy Alligator Forceps | 1301-204 | FDA UDI | Class I | Active |
| Sesamoid Cottle Elevator | 1271-310 | FDA UDI | Class I | Active |
| Debakey Neonatal Clamp | 2100-585B | FDA UDI | Class II | Active |
| Joseph Hook | 199-440 | FDA UDI | Class I | Active |
| Medimark Sheet Tape | 105-552 | FDA UDI | Class I | Active |
| Bipolar Cord | 2700-5251 | FDA UDI | Class II | Active |
| Joseph Masing Elevator | 335-105 | FDA UDI | Class I | Active |
| Debakey Forceps | 2200-105C | FDA UDI | Class I | Active |
| Mayo Scissors | 2400-719 | FDA UDI | Class I | Active |
| Cooley Rib Spreader Retractor | 2500-084A | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 2400-792 | FDA UDI | Class I | Active |
| Ethmoid Pediatric Rongeur | 468-585 | FDA UDI | Class I | Active |
| Medimark Sheet Tape | 105-642 | FDA UDI | Class I | Active |
| Bailey Baby Rib Contractor Child Size | 2500-020 | FDA UDI | Class I | Active |
| McILWRAITH RONGEUR | 1404-845A | FDA UDI | Class I | Active |
| O'connor Skin Hook | 199-406 | FDA UDI | Class I | Active |
| Derf Needle Holder | 132-364 | FDA UDI | Class I | Active |
| Inge Lamina Spreader | 417-064A | FDA UDI | Class I | Active |
| Smith-Petersen Osteotome | 330-612 | FDA UDI | Class I | Active |
| Endonasal DCR Instrumentation Set | 468-354-SET | FDA UDI | Class I | Active |
| Titanium Debakey Neonatal Clamp | 2605-152C | FDA UDI | Class II | Active |
| Sontec I.m. Pin Chuck Key Extension Handle | 1103-186X | FDA UDI | Class I | Active |
| Ragnell Scissors | 1200-426 | FDA UDI | Class I | Active |
| Jewelers Forceps | 2200-0012T | FDA UDI | Class I | Active |
| Buck Ear Curette | 467-374S | FDA UDI | Class I | Active |
| Ryder Needle Holder | 2300-298 | FDA UDI | Class I | Active |
| Heartline Cooley Scissors | 2800-246S | FDA UDI | Class II | Active |
| Titanium Kitzmiller Clamp | 2605-092 | FDA UDI | Class II | Unknown |
| Reduction Forceps | 1103-0665 | FDA UDI | Class I | Active |
| Weitlaner Retractor | 1100-621Q | FDA UDI | Class I | Active |
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