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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
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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 46 of 287| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Atraumatic Grasping Forcep Insert | 2901-245S | FDA UDI | Class II | Unknown |
| Freeman Flap Retractor | 475-522C | FDA UDI | Class I | Active |
| Lester Fixation Tissue Forceps | 14-4620 | FDA UDI | Class I | Active |
| Micasept Debakey Organ Grasping Forceps | 20919-05-040 | FDA UDI | Class II | Active |
| Titanium Satinsky Vena Cava Clamp | 2600-230 | FDA UDI | Class II | Unknown |
| Micasept Applicator | 26932-62 | FDA UDI | Class II | Active |
| Ruskin Rongeur | 315-587Q | FDA UDI | Class I | Active |
| Heine Mpack | X-007.99.671 | FDA UDI | Class II | Active |
| Titanium Debakey Neonatal Clamp | 2605-155C | FDA UDI | Class II | Unknown |
| Heartline Debakey Grasper | 2800-7820S | FDA UDI | Class II | Unknown |
| Tip Cover | 105-734 | FDA UDI | Class I | Active |
| Medimark Sheet Tape | 105-580 | FDA UDI | Class I | Active |
| Sontec-Cottle Osteotome | 1100-479N | FDA UDI | Class I | Active |
| High Resolution Prismatic Binocular Loupes Set | C-000.32.840 | FDA UDI | Class I | Unknown |
| Jacobson Needle Holder | 2300-096 | FDA UDI | Class I | Active |
| Micro Vascular Needle Holder | 2600-765 | FDA UDI | Class I | Active |
| Cooley Subramanian Aortic Clamp | 2100-143 | FDA UDI | Class II | Unknown |
| Liposuction Cannula | 201-146 | FDA UDI | Class I | Active |
| Sontec Suture Ruler | 2800-600 | FDA UDI | Class I | Active |
| Modified Humby Skin Hook | 475-552 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 404-539B | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 1200-782 | FDA UDI | Class I | Active |
| Krayenbuehl Nerve Hook Probe | 400-463T | FDA UDI | Class I | Active |
| Shepard Lens-Holding Forceps | 14-9200 | FDA UDI | Class I | Active |
| Harms-Colibri Tissue Forceps | 14-1845 | FDA UDI | Class I | Active |
| Axial Ring Handle | 2901-074 | FDA UDI | Class II | Active |
| Titanium Fishkind Eye Speculum | T10-1660 | FDA UDI | Class I | Active |
| Swedish Gradle Scissors | 199-550 | FDA UDI | Class I | Active |
| Drysdale Nucleus Manipulator | 12-5851 | FDA UDI | Class I | Active |
| Corneal Trephine Blade | 12-1225 | FDA UDI | Class I | Active |
| Cooley Aortic Clamp | 2100-150 | FDA UDI | Class II | Unknown |
| Freer Elevator | 1100-798J | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 2400-818 | FDA UDI | Class I | Active |
| Resano Scissors | 2400-480 | FDA UDI | Class I | Active |
| McILWRAITH BISTOURI KNIFE | 1271-156 | FDA UDI | Class I | Active |
| M.i.s. Vein Grasping Forceps | 115-380 | FDA UDI | Class I | Active |
| Titanium Debakey Vascular Clamp | 2600-090 | FDA UDI | Class II | Unknown |
| Freeman Retractor | 475-520 | FDA UDI | Class I | Active |
| Plate Bending Pliers | 355-244 | FDA UDI | Class I | Active |
| Lieberman Speculum | T10-1754 | FDA UDI | Class I | Active |
| Metzenbaum Scissors | 1200-514 | FDA UDI | Class I | Active |
| Sontec Laryngoscope Set | 485-315 | FDA UDI | Class I | Active |
| Two Handed Curette | 320-588 | FDA UDI | Class I | Active |
| Richardson Retractor | 207-333 | FDA UDI | Class I | Active |
| Jacobson-Gemini Mixter Forceps | 150-355Q | FDA UDI | Class I | Active |
| Csu Wire Eye Speculum | 10-1042 | FDA UDI | Class I | Active |
| Joseph Scissors | 110-312 | FDA UDI | Class I | Active |
| Hardt Micro Cartilage Osteotome | 330-804M | FDA UDI | Class I | Active |
| Ulrich Bone Clamp | 305-367 | FDA UDI | Class I | Active |
| Harms-Colibri Tissue Forceps | T14-1851 | FDA UDI | Class I | Active |
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