Catalog Number

A001212

Brand Name

AtriCure Isolator Synergy EnCompass Clamp and GuideSystem

Version/Model Number

GPM100

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"

-

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

K210477,K210477,K210477

Product Code

OCL

Product Code Name

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Public Device Record Key

62f35f9d-23a5-4ee5-830a-16423faa850e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 12, 2021

Package DI Number

30840143903377

Quantity per Package

1

Contains DI Package

10840143904134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box