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ABC Dilatation Balloon Catheter FWB-10/80-6/18-S

by Micro-Tech (Nanjing) Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number46932503524092 UDI-DI Date6 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ABC Dilatation Balloon Catheter
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Model / Reference
FWB-10/80-6/18-S
Primary DI / UDI-DI
46932503524092
FDA Product Code
KNQ
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device Class
Class II
Regulation Number
876.5365
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 10 Millimeter
Balloon Length — 8 Centimeter

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Properties

  • 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