Identity
- Trade Name
- IBS™ FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- GUIDE MATRIX KWIRE 2.5 MM FDA UDI
- Model / Reference
- G01 01321 FDA UDI
- Description
- GUIDE MATRIX KWIRE 2.5 MM FDA UDI
Identifiers
- Catalog Number
- G01 01321 FDA UDI
- Primary DI / UDI-DI
- 03760225714317 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Osteotomy 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
No
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: Osteotomy guide, reusable
A surgical instrument designed to outline/define the desired cut-line and mechanically support/guide during osteotomy procedures, intended for single-use use. This device is part of the IN2BONES medical device directory.
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- Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
- UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I
- Truliant CC — Exactech, Inc. · Class II
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
- In2bones
Sources (1)
- FDA UDI ceae65a1-aafb-4e81-9b1d-2ddb53f46efa 35 fields · synced Jul 22, 2026