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Xwire

by Conmed Corporation United States EUDAMEDGUDID

Ref 035450SS, 035260S

Product code OCYEMDN U0699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20653405053931 Basic UDI-DIDate27 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20653405053931 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Gastro-urological guidewire, single-use
Device Name
Non-orthopedic, Non-active, Instrument, Endoscopic, Biliary, Guidewire
Model / Ref / Catalog
035450SS, 035260S
Primary DI / UDI-DI
20653405053931, 20653405053917
Basic UDI-DI
B-20653405053931, B-20653405053917
510(k) Number
FDA Product Code
OCY
EMDN Code
U0699 Urological guidewires - other
GMDN Term
Gastro-urological guidewire, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Size
Outer Diameter — 0.035 Inch
Outer Diameter — 0.89 Millimeter
Length — 260 Centimeter
Length — 450 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
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 (4)

  • EUDAMED cba6926f-4fce-4815-bfcb-eeb07bcb5c4e 61 fields · synced 24 Oct 2026
  • EUDAMED 20653405053917|B-20653405053917 61 fields · synced 18 May 2026
  • FDA UDI 217cefa1-f546-42cc-9f78-00d8048e8e93 37 fields · synced 30 May 2026
  • FDA UDI 9655b11a-3eea-41ba-a407-35e736e5be9b 37 fields · synced 30 May 2026