Catalog Number

-

Brand Name

NA

Version/Model Number

68005YN

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

K060400

Product Code

OCL

Product Code Name

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

Public Device Record Key

f7e8cb89-2f9d-4be8-b310-c10e1dc18c5a

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

May 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-