GUDID 00840682125857

Hangwei GE Medical Systems Co., Ltd.

Stationary basic diagnostic x-ray system, digital
Primary Device ID00840682125857
NIH Device Record Key593af558-3754-441d-80e4-8277d4d2b902
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5896000
Company DUNS654659689
Company NameHangwei GE Medical Systems 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 Datetrue
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
GS100840682125857 [Primary]

FDA Product Code

IXYHolder, radiographic cassette, wall-mounted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-07
Device Publish Date2018-11-06

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