Disposable Biopsy Valve

GUDID 26970401813548

Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

Endoscopic biopsy valve, sterile
Primary Device ID26970401813548
NIH Device Record Key8775912c-0cc9-44db-8b4f-b214d6164ca3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Biopsy Valve
Version Model NumberMD-B-BV01
Company DUNS544434963
Company NameZhe Jiang 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
GS106970401813520 [Primary]
GS116970401813534 [Package]
Contains: 06970401813520
Package: Box [100 Units]
In Commercial Distribution
GS126970401813548 [Package]
Contains: 16970401813534
Package: Case [5 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-03
Device Publish Date2018-12-03

On-Brand Devices [Disposable Biopsy Valve]

26970401813548MD-B-BV01
06970401812585MD-A-BV01

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