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Amethyst HP PTA OTW 0.035" catheter PH0805_00-40S

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 Number06091403562848 UDI-DI Date29 Jan 2026ListedStatusListed 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  • Withdrawn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
Amethyst HP PTA OTW 0.035" catheter
Generic Name
Peripheral angioplasty balloon catheter, basic
Model / Reference
PH0805_00-40S
Primary DI / UDI-DI
06091403562848
FDA Product Code
LIT
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 5.00 Millimeter
Balloon Length — 40 Millimeter

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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