Single Use Guidewire

GUDID 16970401813312

Zhejiang Chuangxiang Medical Technology Co., LTD.

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Primary Device ID16970401813312
NIH Device Record Key53a45970-eea3-4bea-b57a-bd7afb4333b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Guidewire
Version Model NumberMD-A-GW3545
Company DUNS544434963
Company NameZhejiang 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
GS106970401813766 [Primary]
GS116970401813312 [Package]
Contains: 06970401813766
Package: box [10 Units]
In Commercial Distribution
GS126970401810332 [Package]
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 Date2021-10-05
Device Publish Date2021-09-27

On-Brand Devices [Single Use Guidewire]

16970401813312MD-A-GW3545
16970401816146MD-S-GW2545
06970401818648MD-A-GW1845S
06970401818631MD-A-GW1826S
06970401818624MD-A-GW1815S
06970401818266MD-A-GW2150
06970401818259MD-A-GW2145
06970401818242MD-A-GW2136
06970401818235MD-A-GW2126
06970401818228MD-A-GW2120
06970401818211MD-A-GW2115
06970401818204MD-A-GW1845
06970401818198MD-A-GW1850
06970401818181MD-A-GW1836
06970401818174MD-A-GW1826
06970401818167MD-A-GW1820
06970401818150MD-A-GW1815
06970401819102MD-A-GW3220
06970401819096MD-A-GW3215
06970401819089MD-A-GW2550
06970401818709MD-A-GW3215S
06970401818693MD-A-GW2545S
06970401818686MD-A-GW2536S
06970401818679MD-A-GW2526S
06970401818662MD-A-GW2520S
06970401818655MD-A-GW2515S
06970401818297MD-A-GW2536
06970401818280MD-A-GW2520
06970401818273MD-A-GW2515
06970401815708MD-A-GW2526
06970401815692MD-A-GW2545
06970401814008MD-S-GW2515
06970401819317MD-A-GW3826S
06970401819300MD-A-GW3820S
06970401819294MD-A-GW3815S
06970401819287MD-A-GW3550S
06970401819270MD-A-GW3545S
06970401819263MD-A-GW3536S
06970401819256MD-A-GW3526S
06970401819249MD-A-GW3520S
06970401819232MD-A-GW3515S
06970401819225MD-A-GW3836
06970401819218MD-A-GW3826
06970401819201MD-A-GW3820
06970401819195MD-A-GW3815
06970401819188MD-A-GW3550
06970401819171MD-A-GW3536
06970401819164MD-A-GW3520
06970401819157MD-A-GW3515
06970401819140MD-A-GW3250

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