Skip to content

FILAO NC PTCA Dilatation Catheter N023_00-12US

by Natec Medical 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06091403517961 UDI-DI Date26 Mar 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  • Withdrawn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
FILAO NC PTCA Dilatation Catheter
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Reference
N023_00-12US
Primary DI / UDI-DI
06091403517961
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
Size
Balloon Diameter — 3.00 Millimeter
Balloon Length — 12 Millimeter

Related devices

Category: Coronary angioplasty balloon catheter, basic

Other devices from Natec Medical Ltd

See all devices from Natec Medical Ltd →

Properties

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

Other properties (9)

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