Vanguard® Knee Instruments 32-488515
Ref 32-488515
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number889024BDDZ8 00887868497179 | Date30 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00887868497179 | Date25 May 2022 | 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- Withdrawn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
- Trade name
- Vanguard® Knee Instruments
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device name
- Vanguard SSK Tibial Offset Sleeves
- Model / Ref / Catalog
- 32-488515
- Primary DI / UDI-DI
- 00887868497179
- Basic UDI-DI
- 889024BDDZ8
- Direct marketing DI
- 00887868497179
- FDA product code
- LXH
- EMDN code
- L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 888.4540
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (19)
- Supplied sterile: No
- Single use: No
- Implantable: No
- Contains latex: No
- Reprocessed single-use device: No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No