Global Unite
by DePuy Ireland UC EUDAMEDGUDID 36 variants
Active
Ref 2100-70-250Model Orthopaedic Implant Impactor
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0603295a004208G | Date23 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10603295085980 | Date15 Jun 2018 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Generic Name
- Orthopaedic implant impactor, reusable
- Device Name
- Orthopaedic Implant Impactor
- Model / Ref / Catalog
- Orthopaedic Implant Impactor, 2100-70-250, 210070250
- Primary DI / UDI-DI
- 10603295085980
- Basic UDI-DI
- 0603295a004208G
- Direct Marketing DI
- 10603295085980
- FDA Product Code
- HWA
- EMDN Code
- L091104 Orthopaedic prostheses positioners, reusable
- GMDN Term
- Orthopaedic implant impactor, reusable
- Device Class
- Class I
- Regulation Number
- 888.4540
- Market of Registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- IE-MF-000007377
Other devices from DePuy Ireland UC
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: 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