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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 42 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Iol Lens Removing Forceps | 14-5391 | FDA UDI | Class I | Active |
| Bone Graft Impactor | 335-385 | FDA UDI | Class I | Active |
| Jacobson Needle Holder | 2600-6432 | FDA UDI | Class I | Active |
| Lucas Curette | 1102-CSL85 | FDA UDI | Class I | Active |
| Sontec Tischler-Morgan Uterine Biopsy Forceps | 525-281 | FDA UDI | Class I | Unknown |
| Ryder-Castroviejo Needle Holder | 2300-194 | FDA UDI | Class I | Active |
| FRAZiER LAMINA RETRACTOR | 1100-608 | FDA UDI | Class I | Active |
| Reynolds Tenotomy Scissors | 2400-327 | FDA UDI | Class I | Active |
| Yeoman Biospy Punch Rongeur | 90-0664 | FDA UDI | Class I | Active |
| Jacobson Micro Scissors | 2400-629 | FDA UDI | Class I | Active |
| Hartmann Alligator Forceps | 1100-328B | FDA UDI | Class I | Active |
| Rosen Dissector | 412-459 | FDA UDI | Class I | Active |
| Wire Speculum | T10-1014 | FDA UDI | Class I | Active |
| Arkansas Sharpening Stone | 1100-583 | FDA UDI | Class I | Active |
| Potts Artery Scissors | 2400-455 | FDA UDI | Class I | Active |
| Lister Bandage Scissors | 1100-204 | FDA UDI | Class I | Active |
| Ragnell Scissors | 1200-425 | FDA UDI | Class I | Active |
| Stefan Miniature Bone Holding Forceps | 1103-005 | FDA UDI | Class I | Active |
| Schrom Osteotome | 350-835RT | FDA UDI | Class I | Active |
| Bayonet Forceps Blanks | T19023 | FDA UDI | Class I | Active |
| Cilia Jewelers Forceps | 14-6805 | FDA UDI | Class I | Active |
| Corneal Eye Shield | 1100-409SW | FDA UDI | Class I | Active |
| Mictec Magnet Needle Catcher | 20918-80 | FDA UDI | Class II | Unknown |
| Instrument Tray | STE1-2102 | FDA UDI | Class I | Active |
| Waterston Dissector Forceps | 2200-568 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 404-412 | FDA UDI | Class I | Active |
| Debakey Patent Ductus Clamp | 2100-624 | FDA UDI | Class II | Unknown |
| Diethrich Micro Bulldog Clamp | 2100-840 | FDA UDI | Class II | Unknown |
| Hartmann Alligator Forceps | 1100-329 | FDA UDI | Class I | Active |
| Bone Reduction Clamp | 1103-039L | FDA UDI | Class I | Active |
| Introcular Scissors | 13-5710 | FDA UDI | Class I | Active |
| Heine Mpack Unplugged Battery | X-007.99.665 | FDA UDI | Class II | Active |
| Wire Suture Scissors | 1100-308Q | FDA UDI | Class I | Active |
| Micasept Clamp | 20919-07-000 | FDA UDI | Class II | Unknown |
| Hook Scissors | 2901-314L | FDA UDI | Class II | Unknown |
| Cooley Coarctation Clamp | 2100-185 | FDA UDI | Class II | Active |
| Wire Cutter | 1100-528Q | FDA UDI | Class I | Active |
| Sontec Elite Headlamp | 100-9500 | FDA UDI | Class I | Active |
| Hoke Osteotome | 330-702 | FDA UDI | Class I | Active |
| Micro Gerald Forceps | 2200-1441 | FDA UDI | Class I | Active |
| Fomon Raspatory | 345-294 | FDA UDI | Class I | Active |
| Balfour Retractor | 1100-6071-SET | FDA UDI | Class I | Active |
| Arthroscopic Punch | 1272-115 | FDA UDI | Class I | Active |
| Bayonet Suction Tube | 412-902 | FDA UDI | Class II | Unknown |
| V.a.t.s Metzenbaum Slider Scissors | 2405-920 | FDA UDI | Class II | Active |
| Nitinol K Wire Pin | 1106-719B | FDA UDI | Class II | Active |
| Metzenbaum Scissors | 2400-283 | FDA UDI | Class I | Active |
| Gruber Teflon Cartilage Cutting Block | 350-8452 | FDA UDI | Class I | Active |
| Rosen Pick | 467-429T | FDA UDI | Class I | Active |
| Doyen Debakey Intestinal Forceps | 1101-163D | FDA UDI | Class I | Active |
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