Compact Air Drive II Attachments
Ref 511.801, 511.791, 519.510, 511.782, 511.904, 519.530, 511.731, 511.300, 510.200, 310.900, 511.783
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00718K6 | Date30 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Compact Air Drive II AttachmentsCompact Air Drive II
- Device Name
- Compact Air Drive II Double Air HosesTop for SternumRadiolucent Drive
- Model / Reference
- 511.801, 511.791, 519.510, 511.782, 511.904, 519.530, 511.731, 511.300, 510.200, 310.900, 511.783
- Primary DI / UDI-DI
- 07611819102262, 07611819156661, 07611819037168, 07611819077041, 07611819118768, 07611819037182, 07611819107960, 07611819036307, 07611819036260, 07611819019126, 07611819077034
- Basic UDI-DI
- 7611819a00718K6, 7611819a00716K2, 7611819a00720JR, 7611819a00719K8
- Direct Marketing DI
- 0761181910226207611819156661076118190371680761181907704107611819118768076118190371820761181910796007611819036307076118190362600761181901912607611819077034
- EMDN Code
- Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
- Device Class
- Class IClass IIa
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CH-MF-000013345
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Synthes GmbH
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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