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Tearaway Introducer Set INT-105-15

by Galt Medical Corp.

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841268101784 UDI-DI Date3 Jul 2017ListedStatusListed 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  • Withdrawn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
Tearaway Introducer Set
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
INT-105-15
Primary DI / UDI-DI
00841268101784
FDA Product Code
DYB
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Catheter Gauge — 12.5 French

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Properties

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

Other properties (8)

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