Identity
- Trade Name
- Tools - Screws FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Locking Drill Guide, 2.3mm FDA UDI
- Model / Reference
- GUIDELCBS-2.3 FDA UDI
- Description
- Locking Drill Guide, 2.3mm FDA UDI
Identifiers
- Catalog Number
- GUIDELCBS-2.3 FDA UDI
- Primary DI / UDI-DI
- 00842188112843 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical drill guide, reusable
A comprehensive surgical tool designed for simultaneous placement, angle, and guidance of a rotating surgical drill on hard tissue (e.g., bone), intended for general orthopedic surgery. It is typically made of metal and has graduations along its length.
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA UDI 53602b3e-cf02-4836-9f82-edeb51e1f7b1 35 fields · synced Jun 25, 2026