REGIUS MODEL SIGMA

GUDID 04560141933194

KONICA MINOLTA, INC.

Computed radiography digital imaging scanner
Primary Device ID04560141933194
NIH Device Record Key34650edb-bdfa-4834-a6cb-8f8eaee8a6d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGIUS MODEL SIGMA
Version Model NumberA1P8
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
GS104560141933194 [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 SIGMA]

04560141933194A1P8
04560141933170A1P6

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