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GORE GUIDRA Steerable Sheath GDSTS1206520

by Greatbatch Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00821329003462 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Completed Z-0646-2022 FDA Class II initiated 22 Dec 2021

    There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GORE GUIDRA Steerable Sheath
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
GDSTS1206520
Primary DI / UDI-DI
00821329003462
510(k) Number
FDA Product Code
DYB
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K140406)

Show all (12)

Other devices from Greatbatch Ltd

See all devices from Greatbatch Ltd →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Serial Number: No