M.B.T.
by DePuy Ireland UC 49 variants
Ref 2178-63-175Model SPECIALIST 2 REAMER
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0603295a0000886 10603295096320 | Date5 Jan 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10603295096320 | Date24 Sep 2018 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Medullary canal orthopaedic reamer, rigid
- Device Name
- Reamer
- Model / Ref / Catalog
- SPECIALIST 2 REAMER, 2178-63-175, 217863175
- Primary DI / UDI-DI
- 10603295096320
- Basic UDI-DI
- 0603295a0000886
- Direct Marketing DI
- 10603295096320
- FDA Product Code
- HTO
- EMDN Code
- L091102 Orthopaedic prostheses reamers and burs, reusable
- GMDN Term
- Medullary canal orthopaedic reamer, rigid
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 888.4540
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IE-MF-000007377
Other devices from DePuy Ireland UC
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No