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Biodesign G32437

by Cook Biotech Incorporated 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810179631116 UDI-DI Date4 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0834-2025 FDA Class II initiated 22 Nov 2024

    Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Biodesign
Generic Name
Dura mater biomatrix implant
Model / Ref / Catalog
G32437, C-DUR-2X3
Primary DI / UDI-DI
00810179631116
510(k) Number
FDA Product Code
GXQ
GMDN Term
Dura mater biomatrix implant
Device Class
Class II
Regulation Number
882.5910
GUDID distribution status
In Commercial Distribution

Related devices

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Cleared under the same submission (K160869)

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Other devices from Cook Biotech Incorporated

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Properties

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

Other properties (8)

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