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Tearaway Introducer Kit

by Galt Medical Corp. 33 variants

Ref KIT-010-00Model KIT-009-XX

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08412681Tearaway-KITE7 Basic UDI-DI 00841268105096UDI-DIDate21 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00841268105096 UDI-DI Date6 Feb 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tearaway Introducer Kit EUDAMED
Micro-Access Tearaway Introducer Kit GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
KIT-009-XX, KIT-010-00
Primary DI / UDI-DI
00841268105096
Basic UDI-DI
08412681Tearaway-KITE7
FDA Product Code
OFL
EMDN Code
C0503 Cardiovascular introducer sheaths, peel-away
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1340
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Catheter Gauge — 3 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001777
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Galt Medical Corp.

See all devices from Galt Medical Corp. →

Properties

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

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Manufacturing Date: No