Catalog Number

90-3009

Brand Name

Mariner

Version/Model Number

90-3009

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 14, 2020

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

-

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

HXW

Product Code Name

BENDER

Public Device Record Key

bac37eb4-790d-4c64-b7fb-f74ca5a7dca1

Public Version Date

April 14, 2020

Public Version Number

3

DI Record Publish Date

January 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-