DX-D 45C 55DKA

GUDID 05414904197141

DX-D 45C DETECTOR SET

AGFA

Indirect flat panel x-ray detector
Primary Device ID05414904197141
NIH Device Record Key9ce6899c-f49e-452a-821a-a337cf9ad5e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDX-D 45C
Version Model Number6007/201
Catalog Number55DKA
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
GS105414904197141 [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 Number6
Public Version Date2019-06-14
Device Publish Date2016-09-01

Devices Manufactured by AGFA

05414904271124 - SE Suite2023-10-18 Software
05414904208168 - NX 3.02023-07-26
05414904233320 - NX 4.02023-07-26
05414904281321 - DR 4002023-03-31
05414904225066 - Mamoray HDR-C Plus2022-11-24
05414904231678 - Dentus M2 Comfort2022-11-24
05414904231692 - Dentus M2 Comfort2022-11-24
05414904231531 - Dentus Ortholux Register2022-11-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.