Chisel for cement extraction 75.09.64
by Zimmer, Inc. EUDAMEDGUDID
Active
Ref 75.09.64
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number889024AAY27 | Date20 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00889024302570 | Date30 Jun 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Chisel for cement extraction
- Generic Name
- Joint prosthesis implantation kit, reusable
- Model / Ref / Catalog
- 75.09.64
- Primary DI / UDI-DI
- 00889024302570
- Basic UDI-DI
- 889024AAY27
- FDA Product Code
- FZO
- EMDN Code
- L091105 Cementation instruments, reusable
- GMDN Term
- Joint prosthesis implantation kit, reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Zimmer, Inc.
Properties
Other properties (18)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No