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Precision Cut EBT3 GafChromic(TM) Film 158200

by Computerized Imaging Reference Systems, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number00197644515615 UDI-DI Date25 Aug 2023ListedStatusListed GUDID: not 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  • Withdrawn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
Precision Cut EBT3 GafChromic(TM) Film
Generic Name
Medical x-ray film, non-screen
Model / Ref / Catalog
158200
Primary DI / UDI-DI
00197644515615
FDA Product Code
IWZ
GMDN Term
Medical x-ray film, non-screen
Device Class
Class I
Regulation Number
892.1840
GUDID distribution status
Not in Commercial Distribution

Other devices from Computerized Imaging Reference Systems, Inc.

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: 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
  • Manufacturing Date: No