Catalog Number

291-C04

Brand Name

Epimed

Version/Model Number

291-C04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

0cd0e952-f337-435d-81a1-9994894db76e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2017

Package DI Number

10818788022988

Quantity per Package

10

Contains DI Package

00818788022981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case