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Artimes Balloon Dilatation Catheter rev 01

by BrosMed Medical Co., Ltd. 50 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06958481412246 UDI-DI Date10 Sep 2016ListedStatusListed 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  • Withdrawn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
Artimes Balloon Dilatation Catheter
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Ref / Catalog
rev 01, 801-2520U
Primary DI / UDI-DI
06958481412246
FDA Product Code
LOX
GMDN Term
Coronary angioplasty balloon catheter, basic
Device Class
Class II
Regulation Number
870.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coronary angioplasty balloon catheter, basic

Other devices from BrosMed Medical Co., Ltd.

See all devices from BrosMed Medical Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No