Catalog Number

-

Brand Name

Medegen Medical Products, LLC

Version/Model Number

37-97

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"

Yes

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

NNI

Product Code Name

CONTAINER, SPECIMEN, NON-STERILE

Public Device Record Key

9721cccb-ea32-4278-b15e-6a339317d2bc

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-