SkyPlate large

GUDID 00884838065222

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Philips Medical Systems DMC GmbH

Indirect flat panel x-ray detector
Primary Device ID00884838065222
NIH Device Record Key49bfa457-c676-4181-83c4-3c7fc22d58d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkyPlate large
Version Model Number9897-010-00834
Company DUNS314101218
Company NamePhilips Medical Systems DMC GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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
GS100884838065222 [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 Date2016-09-19

On-Brand Devices [SkyPlate large]

00884838084636Solid State X-Ray Imager (Flat Panel/Digital Imager)
00884838074705Solid State X-Ray Imager (Flat Panel/Digital Imager)
00884838065222Solid State X-Ray Imager (Flat Panel/Digital Imager)

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