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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 54 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Debakey Patent Ductus Clamp | 2100-620 | FDA UDI | Class II | Active |
| Pashley Frazier Suction | 1463-503 | FDA UDI | Class II | Active |
| Stretch Pin | 15-30116-07 | FDA UDI | Class II | Active |
| Cooley Bulldog Clamp | 2100-422 | FDA UDI | Class II | Active |
| Debakey Tissue Forceps | 2600-366 | FDA UDI | Class I | Active |
| Molar Extracting Forceps | 1100-580 | FDA UDI | Class I | Active |
| Semb Lung Retractor | 207-407 | FDA UDI | Class I | Active |
| Gelpi Retractor | 1100-6311 | FDA UDI | Class I | Active |
| Nail Splitter | 199-284 | FDA UDI | Class I | Active |
| Barraquer Needle Holder | 15-3930 | FDA UDI | Class I | Active |
| Jacobson Vannas Micro Scissors | 2400-685 | FDA UDI | Class I | Active |
| Cochran Pediatric Retractor | 2500-0071 | FDA UDI | Class I | Active |
| Jacobson Needle Holder | 2300-145 | FDA UDI | Class I | Active |
| Iris Scissors | 1200-011 | FDA UDI | Class I | Active |
| Yasargil Micro Forceps | 2601-283 | FDA UDI | Class I | Active |
| Coupland Suction Tube | 412-676 | FDA UDI | Class II | Active |
| Neurologic Rongeur | 1106-084 | FDA UDI | Class I | Active |
| McCULLOUGH RETRACTOR | 416-157 | FDA UDI | Class I | Active |
| Vertical Extension Bar | 516-866 | FDA UDI | Class I | Active |
| Micro Bone Reduction Clamp | 1103-037B | FDA UDI | Class I | Active |
| Babcock Tissue Forceps | 516-226 | FDA UDI | Class I | Active |
| Thermoplastic Instrument Tray | 1103-702D | FDA UDI | Class I | Active |
| Love Gruenwald Pituitary Rongeur | 404-736 | FDA UDI | Class I | Active |
| Sontec Kerrison Rongeur | 404-426 | FDA UDI | Class I | Active |
| Tissue Nipper | 199-223 | FDA UDI | Class I | Active |
| Jackson Square Basket Forceps | 1100-726 | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 2400-809 | FDA UDI | Class I | Active |
| Arthroscopic Grasping Rongeur Forceps | 1271-005A | FDA UDI | Class I | Active |
| Micro Bone Reduction Clamp | 1103-037A | FDA UDI | Class I | Active |
| Michele Trephine | 1100-460E | FDA UDI | Class I | Active |
| Sontec Freer Skin Hook | 199-401T | FDA UDI | Class I | Active |
| Cooley Retractor | 2500-4757 | FDA UDI | Class I | Active |
| Cinelli Osteotome | 475-763 | FDA UDI | Class I | Active |
| Mayo Scissors | 2400-188 | FDA UDI | Class I | Active |
| Adson Harris Forceps | 1103-809 | FDA UDI | Class I | Active |
| Kistler Manus Bone Reduction Clamp | 1103-033 | FDA UDI | Class I | Active |
| Kilner-Doughty Mouth Gag Blade | 485-484 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 404-4912 | FDA UDI | Class I | Active |
| Luxator Dental Elevator | 1103-3995 | FDA UDI | Class I | Active |
| Jacobson Micro Scissors | 2400-6384 | FDA UDI | Class I | Active |
| Laryngoscopic Alligator Scissors | 1301-104 | FDA UDI | Class I | Active |
| Jansen Bayonet Ear Forceps | 467-315 | FDA UDI | Class I | Active |
| Babcock Tissue Forceps | 516-218Q | FDA UDI | Class I | Active |
| Desmarres Lid Retractor | 10-4226 | FDA UDI | Class I | Active |
| Iris Scissors | 13-7700 | FDA UDI | Class I | Active |
| Gruenwald Suction Forceps | 467-316 | FDA UDI | Class I | Active |
| Root Extracting Forceps | 1103-348S | FDA UDI | Class I | Active |
| Cushing Rongeur | 315-576 | FDA UDI | Class I | Active |
| Black Farrior Ear Specula | 465-239B | FDA UDI | Class I | Active |
| Caspar Cervical Vertebral Retractor Frame | 416-250 | FDA UDI | Class I | Active |
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