Catalog Number

-

Brand Name

CHIKAI 008

Version/Model Number

WAIN-CKI-008-200

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

c96d55b1-ae66-4bf1-bf4b-ca8e831373bb

Public Version Date

November 22, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

24547327098124

Quantity per Package

1

Contains DI Package

04547327098120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-