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Micro-Introducer Kit KIT-100-02

by Galt Medical Corp.

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841268110380 UDI-DI Date19 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  • Withdrawn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
Micro-Introducer Kit
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
KIT-100-02
Primary DI / UDI-DI
00841268110380
FDA Product Code
OFL
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Catheter Gauge — 5 French

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (6)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Manufacturing Date: No