Andorate PearlCatch Single Chamber Polyp Trap

GUDID 26970934720153

Polyp Trap

GA Health Company Limited

Surgical suction system collection container, single-use
Primary Device ID26970934720153
NIH Device Record Key09668774-84f5-48be-b886-d40b5e90ddcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndorate PearlCatch Single Chamber Polyp Trap
Version Model NumberGAR014
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
GS106970934720159 [Primary]
GS116970934720156 [Package]
Contains: 06970934720159
Package: Outerbox [50 Units]
In Commercial Distribution
GS126970934720153 [Package]
Contains: 16970934720156
Package: Carton [6 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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