Catalog Number

LF2019

Brand Name

N/A

Version/Model Number

LF2019

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

K220481,K220481

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

ec15ceb1-b024-4e9f-96f3-d0a25382e945

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 10, 2022

Package DI Number

57613327565312

Quantity per Package

6

Contains DI Package

07613327565317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case