Catalog Number

S400

Brand Name

TriPhasix™

Version/Model Number

S400

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

ELW

Product Code Name

Material, Impression

Public Device Record Key

7fb81065-1553-439c-8b50-34f5e820e63e

Public Version Date

December 24, 2018

Public Version Number

1

DI Record Publish Date

November 23, 2018

Package DI Number

30810000526155

Quantity per Package

25

Contains DI Package

00810000526154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box