Catalog Number

281-2005

Brand Name

Epimed

Version/Model Number

281-2005

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

K041021,K041021

Product Code

GXI

Product Code Name

PROBE, RADIOFREQUENCY LESION

Public Device Record Key

7c4a011e-b06e-465a-9609-6b07d5e17ba1

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2017

Package DI Number

10818788022414

Quantity per Package

25

Contains DI Package

00818788022417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case