Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0330
by Olympus Medical Systems Corporation
Ref N5777430
Active
CE MDD
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/MDD EUDAMED | NumberB-04953170399305 04953170399305 | Date5 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04953170399305 | Date18 Sep 2018 | 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- Withdrawn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
- Trade Name
- Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0330 EUDAMEDSingle Use Sphincterotome V(Distal Wireguided) GUDID
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
- Device Name
- Single Use Sphincterotome/ Needle knife
- Model / Ref / Catalog
- N5777430, KD-VC411Q-0330
- Primary DI / UDI-DI
- 04953170399305
- Basic UDI-DI
- B-04953170399305
- FDA Product Code
- KNS
- EMDN Code
- G03040202 Papillotomes / sphincterotomes, triple (or more) lumen
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 876.4300
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | N5777430 | KD-VC411Q-0330 |
| Device Class | Class IIb | Class II |
Other devices from Olympus Medical Systems Corporation
Properties
Other properties (19)
- 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
- Manufacturing Date: No