RP X-OMAT LO Fixer and Replenisher 8868804

GUDID 60889978868803

RP X-OMAT FIXER AND REPLENISHER 10GL

CARESTREAM HEALTH, INC.

X-ray film processing chemical, automatic X-ray film processing chemical, automatic
Primary Device ID60889978868803
NIH Device Record Key2705cc76-db4a-479e-ba7e-bb02ce35f107
Commercial Distribution StatusIn Commercial Distribution
Brand NameRP X-OMAT LO Fixer and Replenisher
Version Model NumberRP X-OMAT LO Fixer and Replenisher
Catalog Number8868804
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889978868803 [Primary]

FDA Product Code

IWZFilm, radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

On-Brand Devices [RP X-OMAT LO Fixer and Replenisher]

60889978868803RP X-OMAT FIXER AND REPLENISHER 10GL
60889978632664RP X-OMAT LO Fixer and Repl Part A 250GL
60889978239528RP X-OMAT LO FIXER AND REPL PART B 250GL
60889975224381RP X-OMAT LO FIXER AND REPL 2 X 20L

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