Identity
- Trade Name
- MOUNTAINEER FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- MOUNTAINEER OCT SPINAL SYSTEM TEMPLATE 120mm FDA UDI
- Model / Reference
- 288305120 FDA UDI
- Description
- MOUNTAINEER OCT SPINAL SYSTEM TEMPLATE 120mm FDA UDI
Identifiers
- Catalog Number
- 288305120 FDA UDI
- Primary DI / UDI-DI
- 10705034221366 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mountaineer by Depuy Spine, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 4a3bd6a5-b788-4eca-949a-06464d0e2779 36 fields · synced May 31, 2026