Delta Xtend
by DePuy Ireland UC 62 variants
Ref ITH003Model Orthopaedic Implant Impactor
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 | Number0603295a004208G 10603295257936 | Date23 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10603295257936 | 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- Withdrawn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
- Orthopaedic implant impactor, reusable
- Device Name
- Orthopaedic Implant Impactor
- Model / Ref / Catalog
- Orthopaedic Implant Impactor, ITH003
- Primary DI / UDI-DI
- 10603295257936
- Basic UDI-DI
- 0603295a004208G
- Direct Marketing DI
- 10603295257936
- 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