Andorate Four-Chamber Polyp Trap

GUDID 26970934720184

GA Health Company Limited

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Primary Device ID26970934720184
NIH Device Record Key33b9593a-7758-41dc-8242-2c50e8a074b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndorate Four-Chamber Polyp Trap
Version Model NumberGAR023
Company DUNS544333811
Company NameGA Health Company Limited
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970934720180 [Primary]
GS116970934720187 [Package]
Contains: 06970934720180
Package: Outer box [12 Units]
In Commercial Distribution
GS126970934720184 [Package]
Contains: 16970934720187
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

CBCBottle, Collection And Trap, Breathing System (Uncalibrated)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2018-10-23

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