ASAHI Gaia Next 3

GUDID 14547327136317

ASAHI INTECC CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14547327136317
NIH Device Record Key697bf755-bb36-4408-a5ab-93acc269ab55
Commercial Distribution StatusIn Commercial Distribution
Brand NameASAHI Gaia Next 3
Version Model NumberAH14R021P
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

Length190 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104547327136310 [Primary]
GS114547327136317 [Package]
Contains: 04547327136310
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 Date2020-01-20
Device Publish Date2020-01-10

Devices Manufactured by ASAHI INTECC CO., LTD.

04547327153935 - Fielder 182023-09-07
14547327143834 - CROSSLEAD Penetration2023-08-30
14547327143841 - CROSSLEAD Penetration2023-08-30
14547327143858 - CROSSLEAD Penetration2023-08-30
14547327143865 - CROSSLEAD Penetration2023-08-30
14547327143872 - CROSSLEAD Penetration2023-08-30
14547327143889 - CROSSLEAD Penetration2023-08-30
14547327143896 - CROSSLEAD Penetration2023-08-30

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