Biopsy Valve for Olympus® / Fujinon® GI-Endoscope

GUDID 14897106955074

GA Health Company Limited

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Primary Device ID14897106955074
NIH Device Record Keyba92896a-a4a0-4ec3-a655-ab9e979ba319
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiopsy Valve for Olympus® / Fujinon® GI-Endoscope
Version Model NumberEN10233OL
Company DUNS686908512
Company NameGA Health Company Limited
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104897106955077 [Primary]
GS114897106955074 [Package]
Contains: 04897106955077
Package: Box [100 Units]
In Commercial Distribution
GS124897106955071 [Package]
Package: Carton [4 Units]
In Commercial Distribution

FDA Product Code

ODCEndoscope Channel Accessory

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-25

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