REGIUS Plate

GUDID 04560141931381

KONICA MINOLTA, INC.

Digital imaging storage phosphor screen
Primary Device ID04560141931381
NIH Device Record Keyee285e2d-d3a5-45f9-9715-9ad8aa5889b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGIUS Plate
Version Model NumberED64
Company DUNS692076161
Company NameKONICA MINOLTA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104560141931381 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [REGIUS Plate]

04560141931381ED64
04560141931107P49C
04560141931091DYEY
04560141931084E264
04560141931077ED7W
04560141931060EDQY
04560141931053EDNQ
04560141931046EDFV
04560141931039EDE3
04560141931022EDDM

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