Catalog Number

-

Brand Name

NA

Version/Model Number

671PCE

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123733

Product Code

OCL

Product Code Name

Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Public Device Record Key

ffc0d437-21e4-4498-a519-9d2a3d9c2959

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-