Disposable Biopsy Valve 000523

GUDID 26970401814071

ClearGuard Disposable Biopsy Valve for Pentax GI Endoscopes

Zhejiang Chuangxiang Medical Technology Co., LTD.

Endoscopic biopsy valve, sterile
Primary Device ID26970401814071
NIH Device Record Keyf7ff761b-0a5b-4587-acce-dbbc8c829003
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Biopsy Valve
Version Model NumberMDBV1B0000A
Catalog Number000523
Company DUNS544434963
Company NameZhejiang Chuangxiang Medical Technology Co., LTD.
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
GS106970401812400 [Primary]
GS116970401814067 [Package]
Contains: 06970401812400
Package: Box [100 Units]
In Commercial Distribution
GS126970401814071 [Package]
Contains: 16970401814067
Package: Case [500 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-07-18
Device Publish Date2019-06-18

On-Brand Devices [Disposable Biopsy Valve]

16970401817150Non-sterile
16970401817174MD-A-BV02
26970401814361product color: purple
26970401814071ClearGuard Disposable Biopsy Valve for Pentax GI Endoscopes
26970401814057ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes

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