ASAHI Gaia Next 1

GUDID 14547327142264

ASAHI INTECC CO., LTD.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14547327142264
NIH Device Record Keybe16a9a9-98b4-46b5-a7b9-04a56e1001cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameASAHI Gaia Next 1
Version Model NumberAH14R319P
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
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104547327142267 [Primary]
GS114547327142264 [Package]
Contains: 04547327142267
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-12
Device Publish Date2024-06-04

On-Brand Devices [ASAHI Gaia Next 1]

14547327136294AH14R019P
14547327142264AH14R319P

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