Catalog Number

THX05

Brand Name

N/A

Version/Model Number

THX05

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

-

Product Code Name

-

Public Device Record Key

cff73483-5cf4-415e-a639-74adfcbcd75f

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

January 18, 2018

Package DI Number

20705036016028

Quantity per Package

4

Contains DI Package

10705036016021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX