Catalog Number

-

Brand Name

ASAHI SION

Version/Model Number

AHW14R101P

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

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

44b80c83-176f-4797-83fd-95d6a6e57777

Public Version Date

December 16, 2019

Public Version Number

1

DI Record Publish Date

December 07, 2019

Package DI Number

14547327132968

Quantity per Package

5

Contains DI Package

04547327132961

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-