ASAHI Gladius Mongo14 ES

GUDID 14547327123744

ASAHI INTECC CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14547327123744
NIH Device Record Key4e1ee673-1225-487e-9b47-2480e9a5855b
Commercial Distribution StatusIn Commercial Distribution
Brand NameASAHI Gladius Mongo14 ES
Version Model NumberAP14R324S
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
GS104547327123747 [Primary]
GS114547327123744 [Package]
Contains: 04547327123747
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 ES]

14547327123751AP14R324P
14547327123744AP14R324S
14547327123737AP14R024P
14547327123720AP14R024S

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