Catalog Number

-

Brand Name

DTS-3000

Version/Model Number

DTSNPSET

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCY

Product Code Name

Tourniquet, Pneumatic

Public Device Record Key

a01d7e7b-3d29-4deb-a8c9-a3de1cd98afb

Public Version Date

June 24, 2021

Public Version Number

1

DI Record Publish Date

June 16, 2021

Package DI Number

18809315676158

Quantity per Package

2

Contains DI Package

08809315676151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box