COMPACT 2 1190-2-1000

GUDID 04260502640005

Darkroom automated x-ray film processor

PROTEC GmbH & Co. KG

Darkroom automated x-ray film processor
Primary Device ID04260502640005
NIH Device Record Keyb4e02ad2-1655-4138-ada1-b3173ef9fcca
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPACT 2
Version Model Number1190
Catalog Number1190-2-1000
Company DUNS314629130
Company NamePROTEC GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 18 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104260502640005 [Primary]

FDA Product Code

IXWProcessor, Radiographic-Film, Automatic

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 Date2016-10-28

Devices Manufactured by PROTEC GmbH & Co. KG

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04260502640234 - PROGNOST XP2020-12-23 Basic diagnostic x-ray system table, non-powered
04260502640241 - PROGNOST XP2020-12-23 Basic diagnostic x-ray system table, non-powered
04260502640258 - PROGNOST XPE2020-12-23 Basic diagnostic x-ray system table, powered
04260502640265 - PROGNOST XPE2020-12-23 Basic diagnostic x-ray system table, powered
04260502640272 - PROGNOST XPE2020-12-23 Basic diagnostic x-ray system table, powered

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