DIRECTVIEW CR Long-Length Cassette with PQ Screen 1033570

GUDID 60889971033574

CR LLI W/PQ SCREEN

CARESTREAM HEALTH, INC.

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Primary Device ID60889971033574
NIH Device Record Key377a2324-d5b3-49ef-836a-852ba944fee5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECTVIEW CR Long-Length Cassette with PQ Screen
Version Model NumberDIRECTVIEW CR Long-Length Cassette with PQ Screen
Catalog Number1033570
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889971033574 [Primary]

FDA Product Code

IXACassette, radiographic film

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-06

On-Brand Devices [DIRECTVIEW CR Long-Length Cassette with PQ Screen]

60889978754144CR LONG LENGTH PORTABLE CASS W/PQ
60889978010035DV CR LONG-LENGTH CASS PKG W/ PQ
60889971033574CR LLI W/PQ SCREEN

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