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Tropocells PRP 10-TC0040-00-00

by Transcend Biologics, LLC

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 Number00850045520694 UDI-DI Date5 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  • Withdrawn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
Tropocells PRP
Generic Name
Haematological concentrate system preparation kit, platelet concentration
Model / Ref / Catalog
10-TC0040-00-00, TC0040
Primary DI / UDI-DI
00850045520694
FDA Product Code
ORG
GMDN Term
Haematological concentrate system preparation kit, platelet concentration
Device Class
Class II
Regulation Number
864.9245
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (BK110035)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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