Bougie Dilator

GUDID 56970057578632

Jiangsu Vedkang Medical Science and Technology Co.,Ltd.

Oesophageal bougie, single-use
Primary Device ID56970057578632
NIH Device Record Key90126c4b-ea43-4b59-911e-81daae7c0556
Commercial Distribution StatusIn Commercial Distribution
Brand NameBougie Dilator
Version Model NumberVDK-BO-20
Company DUNS544430136
Company NameJiangsu Vedkang Medical Science and Technology Co.,Ltd.
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 Datetrue
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
GS106970057578637 [Primary]
GS156970057578632 [Package]
Contains: 06970057578637
Package: carton [30 Units]
In Commercial Distribution

FDA Product Code

KNQDilator, Esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-28
Device Publish Date2024-08-20

On-Brand Devices [Bougie Dilator]

56970057578632VDK-BO-20
56970057578618VDK-BO-18
56970057578595VDK-BO-16
56970057578571VDK-BO-14
06970057578552VDK-BO-12
56970057578533VDK-BO-10
06970057578514VDK-BO-08
06970057578415VDK-BO

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