Identity
- Trade Name
- GUARDIAN® FDA UDI
- Generic Name
- Revision coated hip femur prosthesis FDA UDI
- Device Name
- GUARDIAN® STEM 11MM X 120MM CoCr W/ PLASMA COLLAR FDA UDI
- Model / Reference
- 25003011 FDA UDI
- Description
- GUARDIAN® STEM 11MM X 120MM CoCr W/ PLASMA COLLAR FDA UDI
Identifiers
- Catalog Number
- 25003011 FDA UDI
- Primary DI / UDI-DI
- M684250030111 FDA UDI
- FDA Product Code
- JDI FDA UDIKRO FDA UDI
- GMDN Term
- Revision coated hip femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 120 Millimeter FDA UDI
Category: Knee femur stem prosthesisRevision coated hip femur prosthesis
Guardian® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ZMR® — Zimmer, 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 II | Pending data |
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Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 2406928c-d530-4ed1-8dde-16bad2a188d2 36 fields · synced Jun 9, 2026