VedDilator; 3-Stage Balloon Dilation Catheter

GUDID 16941513203643

Jiangsu Vedkang Medical Science and Technology Co.,Ltd.

Gastrointestinal/biliary dilation balloon catheter
Primary Device ID16941513203643
NIH Device Record Keyb97b07e8-179f-448d-9abb-1042a37125fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameVedDilator; 3-Stage Balloon Dilation Catheter
Version Model NumberVDK-TBD-15/16.5/18-80-120
Company DUNS544430136
Company NameJiangsu Vedkang Medical Science and 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 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
GS106941513203646 [Primary]
GS116941513203643 [Package]
Contains: 06941513203646
Package: BOX [1 Units]
In Commercial Distribution
GS156941513203641 [Package]
Package: carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 [VedDilator; 3-Stage Balloon Dilation Catheter]

16941513203735VDK-TBD-18/19/20-80-180
16941513203711VDK-TBD-18/19/20-60-230
16941513203674VDK-TBD-15/16.5/18-80-230
16941513203667VDK-TBD-15/16.5/18-80-200
16941513203650VDK-TBD-15/16.5/18-80-180
16941513203643VDK-TBD-15/16.5/18-80-120
16941513203636VDK-TBD-15/16.5/18-80-90
16941513203629VDK-TBD-15/16.5/18-60-230
16941513203612VDK-TBD-15/16.5/18-60-200
16941513203605VDK-TBD-15/16.5/18-60-180
16941513203599VDK-TBD-15/16.5/18-60-120
16941513203582VDK-TBD-15/16.5/18-60-90

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