ASAHI Gladius Mongo14

GUDID 14547327123706

ASAHI INTECC CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14547327123706
NIH Device Record Key7391e711-bcef-4165-b39a-889c56d7f5f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameASAHI Gladius Mongo14
Version Model NumberAP14R323S
Company DUNS690711189
Company NameASAHI INTECC 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter0.014 Inch
Outer Diameter0.014 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS104547327123709 [Primary]
GS114547327123706 [Package]
Contains: 04547327123709
Package: [5 Units]
In Commercial Distribution

FDA Product Code

DQXWire, guide, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-22
Device Publish Date2018-08-31

On-Brand Devices [ASAHI Gladius Mongo14]

14547327123713AP14R323P
14547327123706AP14R323S
14547327123690AP14R023P
14547327123683AP14R023S

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