Identity
- Trade Name
- Zimmer FDA UDI
- Generic Name
- Spinal intraoperative positioning pin, single-use FDA UDI
- Device Name
- K-WIRE, BLUNT 1.5MM X 350MM (14"), SINGLE USE FDA UDI
- Model / Reference
- ZS-0301 FDA UDI
- Description
- K-WIRE, BLUNT 1.5MM X 350MM (14"), SINGLE USE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059117639 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Spinal intraoperative positioning pin, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Zimmer by Tedan Surgical Innovations, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Tedan Surgical Innovations, L.l.c.
Sources (1)
- FDA UDI 4e9e18fd-b4bb-4adc-b3eb-b0c1ac910dd7 34 fields · synced May 31, 2026