Catalog Number

300-1615

Brand Name

Epimed

Version/Model Number

300-1615

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

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

da0f0455-b9b4-4564-aa83-c8a0d6136b6c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 26, 2020

Package DI Number

10818788022681

Quantity per Package

5

Contains DI Package

00818788022684

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case