Identity
- Trade Name
- Z-Guide Wire FDA UDI
- Generic Name
- Orthopaedic bone staple drill bit FDA UDI
- Device Name
- Z-Guide Wire Ø2,6 x 100 FDA UDI
- Model / Reference
- B01 248 S FDA UDI
- Description
- Z-Guide Wire Ø2,6 x 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057217004556 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone staple drill bit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone staple drill bit
Z-Guide Wire by Z-Medical GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple drill bit.
- NITINEX — Vilex, Inc. · Class I
- NITINEX — Vilex, Inc. · Class I
- NITINEX — Vilex, Inc. · Class I
- NITINEX — Vilex, Inc. · Class I
- NITINEX — Vilex, Inc. · Class I
- NITINEX — Vilex, Inc. · Class I
- NITINEX — Vilex, Inc. · Class I
- NITINEX — Vilex, Inc. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Z-Medical GmbH & Co. KG
Sources (1)
- FDA UDI 2b20ed32-2930-425a-a74a-8a55a7225b58 34 fields · synced Jun 8, 2026