Catalog Number

-

Brand Name

ASAHI CHIKAI X 014 soft

Version/Model Number

AIN-CKX-14-200-SFT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MOF

Product Code Name

Guide, wire, catheter, neurovasculature

Public Device Record Key

b700b867-f1e9-4344-a8ad-d19bad3c92f8

Public Version Date

November 22, 2019

Public Version Number

2

DI Record Publish Date

October 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-