Dentus M2 Comfort 34HLM

GUDID 05414904231692

AGFA

Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen Dental x-ray film, non-screen
Primary Device ID05414904231692
NIH Device Record Keyc4f2c9f9-b432-470e-b4aa-29ceeb2e4111
Commercial Distribution StatusIn Commercial Distribution
Brand NameDentus M2 Comfort
Version Model NumberDENTUS M2 COMFORT 3x4cm
Catalog Number34HLM
Company DUNS374444883
Company NameAGFA
Device Count150
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

Customer Support Contacts

Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com

Device Dimensions

Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter
Length3 Centimeter
Width4 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904038802 [Primary]
GS105414904231685 [Unit of Use]
GS105414904231692 [Package]
Contains: 05414904038802
Package: [24 Units]
In Commercial Distribution

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 Date2022-11-24
Device Publish Date2022-11-16

On-Brand Devices [Dentus M2 Comfort]

05414904236949DENTUS M2 Comfort 2x3cm
05414904231654DENTUS M2 COMFORT 2x3cm
05414904231692DENTUS M2 COMFORT 3x4cm
05414904231678DENTUS M2 COMFORT 3x4cm
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