Xwire
by Conmed Corporation United States EUDAMEDGUDID
Ref 035260SS
Product code OCYEMDN U0699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-20653405053955 | Date27 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number20653405053955 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Gastro-urological guidewire, single-use
- Device Name
- Non-orthopedic, Non-active, Instrument, Endoscopic, Biliary, Guidewire
- Model / Ref / Catalog
- 035260SS
- Primary DI / UDI-DI
- 20653405053955
- Basic UDI-DI
- B-20653405053955
- 510(k) Number
- FDA Product Code
- OCY
- EMDN Code
- U0699 Urological guidewires - other
- GMDN Term
- Gastro-urological guidewire, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 876.1500
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
- Size
- Outer Diameter — 0.035 InchLength — 260 CentimeterOuter Diameter — 0.89 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 98940585-e3a3-4ccf-be21-0bd729a68846
- FDA UDI b7016374-554c-498a-b012-3ae991c5fdb4