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Tissue-Tek® Uni-Cassette® 4153-01

by Sakura Finetek USA, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10615233077971 UDI-DI Date18 Dec 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tissue-Tek® Uni-Cassette®
Generic Name
Histology tissue cassette IVD, laboratory processing, single-use
Model / Ref / Catalog
4153-01
Primary DI / UDI-DI
10615233077971
FDA Product Code
IDZ
GMDN Term
Histology tissue cassette IVD, laboratory processing, single-use
Device Class
Class I
Regulation Number
864.3010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Histology tissue cassette IVD, laboratory processing, single-use

Other devices from Sakura Finetek USA, Inc

See all devices from Sakura Finetek USA, Inc →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No