Catalog Number

EFTEMPS-NS

Brand Name

EPIFIX

Version/Model Number

EFTEMPS-NS-US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2021

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

HWT

Product Code Name

Template

Public Device Record Key

d996a0a4-6f3b-46c7-99fc-d81a24af96b9

Public Version Date

November 24, 2021

Public Version Number

4

DI Record Publish Date

July 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-