P-81

GUDID 04560141945777

KONICA MINOLTA, INC.

Indirect flat panel x-ray detector
Primary Device ID04560141945777
NIH Device Record Key448c6ec9-8029-484f-8ceb-73adbd9d4046
Commercial Distribution StatusIn Commercial Distribution
Brand NameP-81
Version Model NumberA8CG
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
GS104560141945777 [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 Number5
Public Version Date2019-05-07
Device Publish Date2018-01-25

On-Brand Devices [P-81]

04560141945845A9YE
04560141945777A8CG

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