Elan 4
Ref GB679R
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number40392390000013462D 04038653299256 | Date19 Jan 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04038653299256 | Date7 May 2020 | 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- Withdrawn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
- Luer/non-ISO80369-standardized linear connector, reusable
- Device Name
- ELAN 4 cleaning device
- Model / Ref / Catalog
- GB679R
- Primary DI / UDI-DI
- 04038653299256
- Basic UDI-DI
- 40392390000013462D
- Direct Marketing DI
- 04038653299256
- FDA Product Code
- GEY
- EMDN Code
- Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
- GMDN Term
- Luer/non-ISO80369-standardized linear connector, reusable
- Device Class
- Class I
- Regulation Number
- 878.4820
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- DE-MF-000005504
Other devices from Aesculap AG
Properties
Other properties (21)
- 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
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No