Staple All-in-One, 08mm, 0°
by Medartis AG
Ref A-4090.01S
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number76300378018PK 07630037889366 | Date21 Nov 2025 | StatusActive |
| United States | GUDID listing GUDID | Number07630037889366 | Date3 Mar 2023 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Staple All-in-One, 08mm, 0° EUDAMEDAptus GUDID
- Generic Name
- Orthopaedic bone staple, non-adjustable
- Device Name
- Staples (sterile)
- Model / Ref / Catalog
- A-4090.01S
- Primary DI / UDI-DI
- 07630037889366
- Basic UDI-DI
- 76300378018PK
- 510(k) Number
- FDA Product Code
- JDR
- EMDN Code
- P09120101 Osteosynthesis staples
- GMDN Term
- Orthopaedic bone staple, non-adjustable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 888.3030
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CH-MF-000022291
- Authorised representative
- Medartis GmbH DE-AR-000005810
Other devices from Medartis AG
Properties
Other properties (17)
- 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