Catalog Number

S400

Brand Name

TriPhasix™

Version/Model Number

S400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

Issuing Agency

In HIBCC

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

ELW

Product Code Name

Material, Impression

Public Device Record Key

23b45f9d-94eb-41b9-ba23-94a5e2874802

Public Version Date

April 01, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M595S4043

Quantity per Package

25

Contains DI Package

M595S4000

Package Discontinue Date

January 01, 2019

Package Status

Not in Commercial Distribution

Package Type

-