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Kerecis SurgiBind® Tendon Protect 6 x 9 cm

by KERECIS hf.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05694310966474 UDI-DI Date3 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Kerecis SurgiBind® Tendon Protect
Generic Name
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
6 x 9 cm, 50242S71D0D
Primary DI / UDI-DI
05694310966474
510(k) Number
FDA Product Code
OWY, FTM
GMDN Term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Device Class
Class II
Regulation Number
878.3300
GUDID distribution status
In Commercial Distribution
Size
Length — 6 Centimeter
Width — 9 Centimeter

Related devices

Cleared under the same submission (K243843)

Other devices from KERECIS hf.

See all devices from KERECIS hf. →

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