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Bigliani/Flatow®
EUDAMEDFDA UDIClass I (EU MDR)
Ref 00-4301-004-00
by Zimmer, Inc.
Identity
- Trade Name
- Bigliani/Flatow® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Zimmer T-Handle EUDAMED
- Model / Reference
- 00-4301-004-00 EUDAMED4301-04 FDA UDI
Identifiers
- Catalog Number
- 00-4301-004-00 FDA UDI
- Primary DI / UDI-DI
- 00889024264434 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024ADQZV EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
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: Rigid endoscope obturator
Bigliani/Flatow® by Zimmer, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 889024ADQZV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
- EUDAMED SRN
- US-MF-000001146
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (2)
- EUDAMED 4b06ff57-ba84-41aa-969d-1446b783e597 61 fields · synced Jun 1, 2026
- FDA UDI d0130ccb-d350-477d-9dc9-f39a6cfdc64f 35 fields · synced May 30, 2026