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Biodesign G55265

by Cook Biotech Incorporated 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00810179631765 UDI-DI Date4 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
G55265, C-BIG-8X10
Primary DI / UDI-DI
00810179631765
510(k) Number
FDA Product Code
OXK
GMDN Term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Device Class
Class II
Regulation Number
878.3300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K133306)

Show all (12)

Other devices from Cook Biotech Incorporated

See all devices from Cook Biotech Incorporated →

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