DRYSTAR DT 2 MAMMO ERE5C

GUDID 05414904042816

Medical printer film Medical printer film Medical printer film Medical printer film Medical printer film

Primary Device ID	05414904042816
NIH Device Record Key	aa47966a-a9a5-41ac-a2a3-415680eb49f3
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRYSTAR DT 2 MAMMO
Version Model Number	DRYSTAR DT 2 MAMMO 20x25
Catalog Number	ERE5C
Company DUNS	374444883
Company Name	AGFA
Device Count	100
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h).
Handling Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h).
Handling Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h).
Handling Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h).
Handling Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h).
Handling Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
GS1	05414904015490 [Primary]
GS1	05414904041956 [Unit of Use]
GS1	05414904042816 [Package] Contains: 05414904015490 Package: [5 Units] In Commercial Distribution

IWZ	Film, radiographic

Steralize Prior To Use	false
Device Is Sterile	false