REGIUS Cassette

GUDID 04560141928282

KONICA MINOLTA, INC.

Digital imaging cassette
Primary Device ID04560141928282
NIH Device Record Keyeae94755-558e-482a-98ec-48095b2c6410
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGIUS Cassette
Version Model NumberA2VX
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
GS104560141928282 [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 Cassette]

04560141933743A1PH
04560141933736A1PG
04560141933361A1PJ
04560141933248A3P6
04560141933231A3P5
04560141933224A3P4
04560141933217A3P3
04560141933200A3P1
04560141928411E2LT
04560141928381E2F7
04560141928367E2E3
04560141928350A2RS
04560141928329A2NE
04560141928305A1GU
04560141928282A2VX
04560141928268A2TC

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