Catalog Number

SXSPT01

Brand Name

Sentrinex

Version/Model Number

SXSPT01

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

NAD

Product Code Name

Dressing,wound,occlusive

Public Device Record Key

a65c5f70-5a8c-4030-8c4c-9abfa1ec18f7

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

February 03, 2016

Package DI Number

10801741117036

Quantity per Package

100

Contains DI Package

00801741117039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA