REGIUS MODEL 110

GUDID 04560141921788

KONICA MINOLTA, INC.

Computed radiography digital imaging scanner
Primary Device ID04560141921788
NIH Device Record Key872db74a-393c-4b56-8f75-2853ad3dc0fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGIUS MODEL 110
Version Model NumberJFF7
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 Identifiers

Device Issuing AgencyDevice ID
GS104560141921788 [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 Date2019-04-23
Device Publish Date2016-09-19

On-Brand Devices [REGIUS MODEL 110]

04560141936706A5RE
04560141936690A5RD
04560141921788JFF7

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