INT,FineThrough

GUDID 26950900959961

0.018"*180cm,straight

Shanghai Kindly Medical Instruments Co., Ltd.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID26950900959961
NIH Device Record Key88a16e08-75b2-45c6-b566-1e5d41109479
Commercial Distribution StatusIn Commercial Distribution
Brand NameINT,FineThrough
Version Model NumberHG184SF
Company DUNS420827639
Company NameShanghai Kindly Medical Instruments 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
GS106950900959967 [Primary]
GS116950900959964 [Package]
Contains: 06950900959967
Package: box [5 Units]
In Commercial Distribution
GS126950900959961 [Package]
Contains: 06950900959967
Package: box [10 Units]
In Commercial Distribution
GS146950900959965 [Package]
Contains: 06950900959967
Package: carton [100 Units]
In Commercial Distribution
GS156950900959962 [Package]
Contains: 06950900959967
Package: carton [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-29
Device Publish Date2023-08-21

On-Brand Devices [INT,FineThrough]

269509009599610.018"*180cm,straight
269509009195210.018"*300cm,straight
2695090090689718 PV-3 x 300 cm
2695090090688014 PV-3 x 300 cm

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