Aesculap
by Aesculap AG 1,000+ variants
Ref OK926R
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 | Number40392390000006642P 04038653177820 | Date2 Sep 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04038653177820 | Date26 Jul 2017 | 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- Withdrawn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
- Nasal dilator
- Device Name
- Frontal sinus dilator
- Model / Ref / Catalog
- OK926R
- Primary DI / UDI-DI
- 04038653177820
- Basic UDI-DI
- 40392390000006642P
- Direct Marketing DI
- 04038653177820
- FDA Product Code
- LWF
- EMDN Code
- L149005 ENT probes, reusable
- GMDN Term
- Nasal dilator
- Device Class
- Class I
- Regulation Number
- 874.3900
- 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 (20)
- Sterile: No
- Single Use: No
- Implantable: 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