CHIKAI 10

GUDID 24547327085353

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 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 ID24547327085353
NIH Device Record Key594e3c05-0fda-451a-9780-432d3c9e70d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHIKAI 10
Version Model NumberWAIN-CKI-10-300
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

Length300 Centimeter
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter
Outer Diameter0.01 Inch
Length300 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104547327085359 [Primary]
GS124547327085353 [Package]
Contains: 04547327085359
Package: [1 Units]
In Commercial Distribution

FDA Product Code

MOFGUIDE, WIRE, CATHETER, NEUROVASCULATURE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-22
Device Publish Date2016-09-16

On-Brand Devices [CHIKAI 10]

24547327085353WAIN-CKI-10-300
24547327085346WAIN-CKI-10-200

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.