Identity
- Trade Name
- Profemur FDA UDI
- Generic Name
- Revision coated hip femur prosthesis FDA UDI
- Device Name
- Profemur Gladiator Thin HA Classic with Collar EUDAMEDPROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 EXT FDA UDI
- Model / Reference
- PGHCCLE6 EUDAMEDFDA UDI
- Description
- PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 EXT FDA UDI
Identifiers
- Catalog Number
- PGHCCLE6 FDA UDI
- Primary DI / UDI-DI
- 00192629250369 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192629PROFGTHACWCCLYW EUDAMED
- Secondary DI
- M684PGHCCLE61 EUDAMED
- 510(k) Number
- K200007 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDI
- EMDN Code
- P090804010201 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT EUDAMED
- GMDN Term
- Revision coated hip femur prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Conditional FDA UDI
Category: Revision coated hip femur prosthesis
Profemur by MicroPort Orthopedics Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (2)
- FDA UDI 7af400a4-3603-4f20-bba6-306b0ca598b5 36 fields · synced Oct 10, 2026
- EUDAMED 3293768f-1af0-4f5c-82ed-469dab644e92 61 fields · synced Oct 10, 2026