Catalog Number

D 9421

Brand Name

MABIS DMI

Version/Model Number

D 9421

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 02, 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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HFW

Product Code Name

Clamp, Umbilical

Public Device Record Key

95a3068f-dc93-4b03-b60f-58ac5a633bab

Public Version Date

September 03, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-