P-61

GUDID 04560141945821

KONICA MINOLTA, INC.

Indirect flat panel x-ray detector
Primary Device ID04560141945821
NIH Device Record Keyfd5bab9a-591d-4940-8a42-6cbde4e12b2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameP-61
Version Model NumberA9YC
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 Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104560141945821 [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 Date2020-05-13
Device Publish Date2017-01-04

On-Brand Devices [P-61]

04560141945821A9YC
04560141945753A8CE

Trademark Results [P-61]

Mark Image

Registration | Serial
Company
Trademark
Application Date
P-61
P-61
74157925 1685901 Dead/Cancelled
BAYER CORPORATION
1991-04-17

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