Catalog Number

-

Brand Name

THERAPACK, LLC

Version/Model Number

15610G

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

-

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

2afea84a-b8a8-435a-8c46-0c52eb0a0f3a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-