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Embedding Cassette EC0205PXT

by Typenex Medical, LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810049681265 UDI-DI Date16 Nov 2022ListedStatusListed 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  • Withdrawn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
Embedding Cassette
Generic name
Tissue embedding mould IVD, single-use
Model / reference
EC0205PXT
Primary DI / UDI-DI
00810049681265
FDA product code
IDZ
GMDN term
Tissue embedding mould IVD, single-use
Device class
Class I
Regulation number
864.3010
GUDID distribution status
In Commercial Distribution

Other devices from Typenex Medical, LLC

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Properties

  • Single use
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No