Catalog Number

257-1615

Brand Name

Epimed

Version/Model Number

257-1615

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

K041021,K041021

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

e9b37174-cd07-488a-a966-1b6ac6ec1bee

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2020

Package DI Number

10818788023244

Quantity per Package

25

Contains DI Package

00818788023247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case