Single Use Guidewire

GUDID 26970401813913

Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

Gastro-urological guidewire, single-use
Primary Device ID26970401813913
NIH Device Record Key0caeb448-7ad0-4a87-b138-bd36fa5b81cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Guidewire
Version Model NumberMD-S-GW3545
Company DUNS544434963
Company NameZhe Jiang ChuangXiang Medical 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 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
GS106970401813490 [Primary]
GS116970401813909 [Package]
Contains: 06970401813490
Package: Box [10 Units]
In Commercial Distribution
GS126970401813913 [Package]
Contains: 16970401813909
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

OCYEndoscopic Guidewire, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-01
Device Publish Date2019-03-23

Devices Manufactured by Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

16970401815095 - Disposable Valve Sets2020-05-01
26970401814286 - Non-Rotatable Snares2019-10-31
26970401814262 - Non-Rotatable Snares2019-10-31
26970401814309 - Rotatable Snares2019-10-31
26970401813739 - Cleaning Brush2019-10-07
26970401813456 - Cleaning Brush2019-10-07
26970401813470 - Cleaning Brush2019-10-07
26970401813647 - Cleaning Brush2019-10-07

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