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PriMatrix Ag 607-101-440

by Tei Biosciences Inc.

PriMatrix Ag 607-101-440 is an animal-derived wound matrix dressing (FDA unclassified; FDA product code FRO, Dressing, wound, drug) made by Tei Biosciences Inc., cleared under FDA 510(k) K100261 on 10 Dec 2010 and listed in FDA GUDID since 14 Oct 2015 (UDI-DI 10381780113522), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

Recall on shared 510(k) K100261; other models may be affected

Documents

510(k) K100261

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780113522 UDI-DI Date14 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK100261 Date10 Dec 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100261 decided 10 Dec 2010 Active
  • FDA GUDID UDI-DI 10381780113522 listed 14 Oct 2015 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2082-2023 FDA Class II initiated 23 May 2023 on shared 510(k) K100261
    • Ongoing Z-2081-2023 FDA Class II initiated 23 May 2023 on shared 510(k) K100261
    • Ongoing Z-2080-2023 FDA Class II initiated 23 May 2023 on shared 510(k) K100261

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K100261
  2. Listed FDA GUDID 10381780113522
  3. Recall initiated FDA recalls Z-2082-2023
  4. Recall initiated FDA recalls Z-2081-2023
  5. Recall initiated FDA recalls Z-2080-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PriMatrix Ag
Generic name
Animal-derived wound matrix dressing
Model / Ref / Catalog
607-101-440
Primary DI / UDI-DI
10381780113522
510(k) Number
FDA product code
FRO
GMDN term
Animal-derived wound matrix dressing
Device class
U
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Animal-derived wound matrix dressing

Cleared under the same submission (K100261)

and 8 more cleared under K100261

Similar devices

Other devices filed under FDA product code FRO (Dressing, wound, drug).

Other devices from Tei Biosciences Inc.

See all devices from Tei Biosciences Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)