Catalog Number

LF4318

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 02, 2020

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

K150538,K150538

Product Code

NUJ

Product Code Name

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

Public Device Record Key

1e6739fa-76d1-49e6-ac54-857be34df8c6

Public Version Date

July 02, 2020

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

50885825017885

Quantity per Package

6

Contains DI Package

00885825017880

Package Discontinue Date

July 02, 2020

Package Status

Not in Commercial Distribution

Package Type

case