KEYSURGICAL® PolypTrap with 2 removable chambers

GUDID 14897106951489

GA Health Company Limited

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Primary Device ID14897106951489
NIH Device Record Key4259d75e-c2a3-4080-ba80-7c6db539c669
Commercial Distribution StatusIn Commercial Distribution
Brand NameKEYSURGICAL® PolypTrap with 2 removable chambers
Version Model NumberEN10112
Company DUNS686908512
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104897106951482 [Primary]
GS114897106951489 [Package]
Contains: 04897106951482
Package: Box [12 Units]
In Commercial Distribution
GS124897106951486 [Package]
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 Number2
Public Version Date2022-11-28
Device Publish Date2022-04-11

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