DigitalDiagnost C50

GUDID 00884838095199

Stationary x-ray system

Philips Healthcare (Suzhou) Co., Ltd.

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Primary Device ID00884838095199
NIH Device Record Key91ed4d9e-2b28-4a43-a3c8-830c260ebe99
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigitalDiagnost C50
Version Model Number712204
Company DUNS421265537
Company NamePhilips Healthcare (Suzhou) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com
Phone+1(800)722-9377
Emailmary.zhu@philips.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]
GS100884838095199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [DigitalDiagnost C50]

00884838082366The DigitalDiagnost C50 is intended for use in generating radiographic images of human anatomy b
00884838095199Stationary x-ray system

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