92-08232
Ref 92-08232Model 08858251001899TY
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 | Number08858251001899TY 07613252005230 | Date22 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07613252005230 | Date24 Sep 2015 | 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- Withdrawn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
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Device name
- Universal - Mandible and MP Plates
- Model / Ref / Catalog
- 92-08232, 08858251001899TY
- Primary DI / UDI-DI
- 07613252005230
- Basic UDI-DI
- 08858251001899TY
- FDA product code
- JEY
- EMDN code
- P09120503 Osteosynthesis screw-plate systems
- GMDN term
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 872.4760
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |
Other devices from Stryker Leibinger
Properties
Other properties (19)
- Supplied sterile: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): 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
- Premarket exempt: No
- Serial number: No
- Expiration date: No