Catalog Number

6U073S01

Brand Name

eNAT®

Version/Model Number

6U073S01

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

QBD

Product Code Name

Microbial Nucleic Acid Storage And Stabilization Device

Public Device Record Key

76a8e911-b39a-455a-9bb6-d4a8492607f6

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

February 16, 2021

Package DI Number

58053326009698

Quantity per Package

10

Contains DI Package

38053326009694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-