G7® Dual Mobility 110024736
Ref 110024736
Active
CE MDD
Valid until
Not listed
FDA recalls
1 ongoingDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00880304712928 00880304712928 | Date1 Nov 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00880304712928 | Date23 Nov 2021 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Ongoing Z-1284-2023
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- G7® Dual Mobility
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable
- Device Name
- G7 Dual Mobility Liner Trials
- Model / Ref / Catalog
- 110024736
- Primary DI / UDI-DI
- 00880304712928
- Basic UDI-DI
- B-00880304712928
- 510(k) Number
- FDA Product Code
- LPH, OQG, LZO, KWY
- EMDN Code
- L091104 Orthopaedic prostheses positioners, reusable
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 888.3358, 888.3353, 888.3390
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: 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
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No