Catalog Number

-

Brand Name

Globe Scientific

Version/Model Number

513077A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NNK

Product Code Name

Container, Specimen Mailer And Storage, Non-Sterile

Public Device Record Key

8d1badc1-d70b-4383-a2ac-7041e9bda042

Public Version Date

December 04, 2019

Public Version Number

1

DI Record Publish Date

November 26, 2019

Package DI Number

00840095606950

Quantity per Package

120

Contains DI Package

00840095606967

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case