Catalog Number

LF4418

Brand Name

N/A

Version/Model Number

LF4418

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

K180451,K180451

Product Code

NUJ

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Public Device Record Key

f4d6dda1-26c2-40d0-ada6-bffb5fce646e

Public Version Date

August 21, 2018

Public Version Number

3

DI Record Publish Date

April 24, 2018

Package DI Number

57613327417840

Quantity per Package

6

Contains DI Package

07613327417845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case