DR 400 51FS1

GUDID 05414904176252

DR 400 SYSTEM

AGFA

Stationary basic diagnostic x-ray system, digital
Primary Device ID05414904176252
NIH Device Record Key18ab25e3-d4a9-42df-8d65-79dfc083fea0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDR 400
Version Model Number5520/100
Catalog Number51FS1
Company DUNS374444883
Company NameAGFA
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904176252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid state x-ray imager (flat panel/digital imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-14
Device Publish Date2016-09-01

On-Brand Devices [DR 400]

05414904217870DR 400 5520/200 Automatic
05414904176252DR 400 SYSTEM
054149042813215520/150

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