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Instrument
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1235-C-1075Model 08858251005231SU
Identity
- Trade Name
- MDM EUDAMEDINSTRUMENT FDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Device Name
- TF-025 - Class IIa - Hip - Trial Insert EUDAMEDADM/MDM SLEEVE TRIAL (FOR 22.2MM HEADS ONLY) FDA UDI
- Model / Reference
- 1235-C-1075 EUDAMEDFDA UDI08858251005231SU EUDAMED
- Description
- ADM/MDM SLEEVE TRIAL (FOR 22.2MM HEADS ONLY) FDA UDI
Identifiers
- Catalog Number
- 1235-C-1075 FDA UDI
- Primary DI / UDI-DI
- 07613327195798 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251005231SU EUDAMED
- Direct Marketing DI
- 07613327195798 EUDAMED
- FDA Product Code
- KWZ FDA UDILZO FDA UDIMBL FDA UDIMAY FDA UDILWJ FDA UDIKWL FDA UDILPH FDA UDIJDI FDA UDIMEH FDA UDIKWY FDA UDIHWC FDA UDI
- EMDN Code
- V06010101 HIP PROSTHESES TESTING DEVICES EUDAMED
- GMDN Term
- Femoral head prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3310 FDA UDI888.3353 FDA UDI888.3358 FDA UDI888.3360 FDA UDI888.3350 FDA UDI888.3390 FDA UDI888.3040 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femoral head prosthesis trial
Instrument by Howmedica Osteonics Corp. — 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
- Howmedica Osteonics Corp.
Sources (2)
- FDA UDI ea52bc6d-2efd-4d25-963c-5005aaf2ba20 35 fields · synced Oct 7, 2026
- EUDAMED 017f157e-50f9-4a0c-bfdd-757cf3a96dd9 61 fields · synced Oct 7, 2026