Catalog Number

650-4001-0000

Brand Name

MABIS DMI

Version/Model Number

650-4001-0000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2022

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

-

Product Code Name

-

Public Device Record Key

7b41f114-4403-47dd-866f-c92b0a37e0c8

Public Version Date

September 22, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10041298400100

Quantity per Package

20

Contains DI Package

00041298400103

Package Discontinue Date

September 21, 2022

Package Status

Not in Commercial Distribution

Package Type

Master Carton