Single-use Ureteral Access Sheath

GUDID 06972197482270

Hunan Vathin Medical Instrument Co., Ltd

Ureteral introduction sheath
Primary Device ID06972197482270
NIH Device Record Key4eaaca15-0bff-40a3-9fec-acdf70aa9655
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-use Ureteral Access Sheath
Version Model NumberUA-S1B01
Company DUNS554484862
Company NameHunan Vathin Medical Instrument 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972197482270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEDEndoscopic Access Overtube, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-12
Device Publish Date2024-11-04

On-Brand Devices [Single-use Ureteral Access Sheath]

06972197482317UA-S1D01
06972197482300UA-S1D00
06972197482294UA-S1C01
06972197482287UA-S1C00
06972197482270UA-S1B01
06972197482263UA-S1B00
06972197482256UA-S1A01
06972197482249UA-S1A00
06972197482232UA-S1801
06972197482225UA-S1800
06972197483512UA-S1D03
06972197483505UA-S1D02
06972197483499UA-S1C03
06972197483482UA-S1C02
06972197483475UA-S1B03
06972197483468UA-S1B02
06972197483451UA-S1A03
06972197483444UA-S1A02
06972197483437UA-S1803
06972197483420UA-S1802

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