Surgical Instrument
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- DRIVER HANDPIECE F/ IMP. CM SHORT EUDAMEDSURGICAL INSTRUMENT FDA UDI
- Generic Name
- Surgical screwdriver, single-use, non-sterile FDA UDI
- Device Name
- DRIVER EUDAMEDDRIVER HANDPIECE C. MORSE FDA UDI
- Model / Reference
- CTMD 20 EUDAMEDFDA UDIDRIVER WITHOUT DLC EUDAMED
- Description
- DRIVER HANDPIECE C. MORSE FDA UDI
Identifiers
- Catalog Number
- CTMD 20 FDA UDI
- Primary DI / UDI-DI
- 07899995207340 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000011JK EUDAMED
- 510(k) Number
- K201688 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical screwdriver, single-use, non-sterile
Surgical Instrument by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, single-use, non-sterile.
- EASYOUT — Biomet Orthopedics, Inc. · Class I
- FuzeFix Large — FUSION ORTHOPEDICS, LLC · Class II
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class II
- T10 Screwdriver, Short — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- HEX EXTRACTOR, LONG HUDSON — Biomet Orthopedics, Inc. · Class I
- EASY OUT, S-COUPLE — Biomet Orthopedics, Inc. · Class I
- AOS Hex Screw Driver 2.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- Screwdriver Spanner — Neurovention LLC · Class I
Cleared under the same submission
K201688 also covers:
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 66e2f6c4-f27b-43d5-9d50-e4f29109a769 35 fields · synced Jul 23, 2026
- EUDAMED fce3fa1d-2dbc-4279-89d8-e3cf8ee4de50 61 fields · synced Jul 23, 2026