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Guidewire GW3-45S

by Taewoong Medical South Korea GUDID

Product code OCY

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809909421532 UDI-DIDate24 Apr 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Guidewire
Generic Name
Gastro-urological guidewire, single-use
Model / Ref / Catalog
GW3-45S
Primary DI / UDI-DI
08809909421532
FDA Product Code
OCY
GMDN Term
Gastro-urological guidewire, single-use
Device Class
Class II
Regulation Number
876.1500
Commercial Distribution
In Commercial Distribution

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (7)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No

Sources (1)

  • FDA UDI 905a649f-0249-4efa-b348-41cd89321fd8 35 fields · synced 23 Oct 2026