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Instrument
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 7555-0007Model 08858251003215SG
Identity
- Trade Name
- INSTRUMENT EUDAMEDFDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- TF-025 - Class IIa - Hip - Neck Trial EUDAMEDInsignia Hip Stem High Neck Trial FDA UDI
- Model / Reference
- 7555-0007 EUDAMEDFDA UDI08858251003215SG EUDAMED
- Description
- Insignia Hip Stem High Neck Trial FDA UDI
Identifiers
- Catalog Number
- 7555-0007 FDA UDI
- Primary DI / UDI-DI
- 07613327520071 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251003215SG EUDAMED
- Direct Marketing DI
- 07613327520071 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- V06010101 HIP PROSTHESES TESTING DEVICES EUDAMED
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 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
Yes
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
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
Category: Femoral stem prosthesis trial
Instrument by Howmedica Osteonics Corp. — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (2)
- FDA UDI ecb287ed-23b4-4cc8-828b-6961b0ab2ac0 35 fields · synced Oct 8, 2026
- EUDAMED 3c5566e3-ec8a-4e66-856e-2ba89daea690 61 fields · synced Oct 8, 2026