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Guidewire SGW-056-60

by Galt Medical Corp.

Ref SGW-056-60Model SGW-XXX-xx

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

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 Number08412681Guidewires<90cm2K Basic UDI-DIDate4 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00841268101494 UDI-DIDate3 Jul 2017ListedStatusListed 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.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2917-2026 FDA Class II initiated 26 Jun 2026

    Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

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  • Withdrawn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
Guidewire
Generic Name
Peripheral vascular guidewire, manual
Model / Ref / Catalog
SGW-056-60, SGW-XXX-xx
Primary DI / UDI-DI
00841268101494
Basic UDI-DI
08412681Guidewires<90cm2K
FDA Product Code
DQX
EMDN Code
C04020199 Peripheral vascular diagnostic guidewires- other
GMDN Term
Peripheral vascular guidewire, manual
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1330
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Outer Diameter — 0.014 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Peripheral vascular guidewire, manual

Cleared under the same submission (K021990)

Show all (12)

Other devices from Galt Medical Corp.

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Properties

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

Other properties (18)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No