Identity
- Trade Name
- M.B.T. EUDAMEDNA FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Broach EUDAMEDM.B.T. REVISION TIBIAL 2 DEGREE BROACH 53mm FDA UDI
- Model / Reference
- M.B.T. Broach EUDAMED2178-63-115 EUDAMEDFDA UDI
- Description
- M.B.T. REVISION TIBIAL 2 DEGREE BROACH 53mm FDA UDI
Identifiers
- Catalog Number
- 217863115 FDA UDI
- Primary DI / UDI-DI
- 10603295096122 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005018H EUDAMED
- Direct Marketing DI
- 10603295096122 EUDAMED
- FDA Product Code
- HTQ FDA UDI
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland 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
No
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
M.b.t. by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0603295a005018H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 73b4b225-dd88-4c03-b179-66daea631f54 61 fields · synced Jul 24, 2026
- FDA UDI 47d6a997-2d18-4098-9b8e-ba600a863c07 35 fields · synced May 30, 2026