Dentus Ortholux 39N8R

GUDID 05414904231593

Dental x-ray film, screen

Primary Device ID	05414904231593
NIH Device Record Key	fc9c8174-e637-4635-985f-903e587240f8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dentus Ortholux
Version Model Number	DENTUS ORTHOLUX 20X25
Catalog Number	39N8R
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

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). Only open in darkroom.
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). Only open in darkroom.
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). Only open in darkroom.
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). Only open in darkroom.
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). Only open in darkroom.

Device Issuing Agency	Device ID
GS1	05414904010860 [Primary]
GS1	05414904231586 [Unit of Use]
GS1	05414904231593 [Package] Contains: 05414904010860 Package: [5 Units] In Commercial Distribution

IWZ	Film, radiographic

Steralize Prior To Use	false
Device Is Sterile	false