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Phenom™ Catheter FG15135-1030-1SV02

by Cathera, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00814584028974 UDI-DI Date26 Oct 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Phenom™ Catheter
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
FG15135-1030-1SV02, FG15135-1030-1S
Primary DI / UDI-DI
00814584028974
FDA Product Code
KRA, DQY
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1210, 870.1250
GUDID distribution status
Not in Commercial Distribution
Size
Lumen/Inner Diameter — 0.027 Inch
Length — 135 Centimeter

Other devices from Cathera, Inc.

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