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Oncology Portal Pack for Localization / PPL Film

by Carestream Health, Inc. 3 variants

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 8 Jun 2026. What this means

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number40889978013964 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Medical x-ray film, non-screen
Model / Ref / Catalog
Oncology Portal Pack for Localization / PPL Film, 8013963
Primary DI / UDI-DI
40889978013964
FDA Product Code
IWZ
GMDN Term
Medical x-ray film, non-screen
Device Class
Class I
Regulation Number
892.1840
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical x-ray film, non-screen

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • 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
  • Manufacturing Date: No