Catalog Number

A001166

Brand Name

EPi-Sense ST Coagulation Device

Version/Model Number

EPiST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

OCM

Product Code Name

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Public Device Record Key

ca4534f5-6730-47fd-a964-92994cdbdb32

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

30840143901656

Quantity per Package

1

Contains DI Package

10840143904585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box