StopCon-Cap Pentax® Cap with Air/Water tubing for Pentax® GI Endoscope

GUDID 14897106954114

GA Health Company Limited

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Primary Device ID14897106954114
NIH Device Record Keyc59024bb-ebde-4b37-aa0b-27ad5cebc8d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameStopCon-Cap Pentax® Cap with Air/Water tubing for Pentax® GI Endoscope
Version Model NumberEN10902B
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 Usefalse
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
GS104897106954117 [Primary]
GS114897106954114 [Package]
Contains: 04897106954117
Package: Box [10 Units]
In Commercial Distribution
GS124897106954111 [Package]
Package: Carton [4 Units]
In Commercial Distribution

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-08
Device Publish Date2022-01-31

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