DRYPRO SD-PM

GUDID 64560141934896

MEDICAL IMAGING FILM

KONICA MINOLTA, INC.

Medical x-ray film, non-screen
Primary Device ID64560141934896
NIH Device Record Key2688df30-67b6-4e24-9252-016d6434fe11
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRYPRO SD-PM
Version Model NumberA5G5
Company DUNS692076161
Company NameKONICA MINOLTA, INC.
Device Count125
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS144560141934892 [Primary]
GS164560141934896 [Package]
Contains: 44560141934892
Package: Box [4 Units]
In Commercial Distribution
GS184560141934890 [Unit of Use]

FDA Product Code

IWZFilm, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-28
Device Publish Date2022-09-20

On-Brand Devices [DRYPRO SD-PM]

64560141934896MEDICAL IMAGING FILM
64560141934889MEDICAL IMAGING FILM

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