Catalog Number

LF1937

Brand Name

N/A

Version/Model Number

LF1937

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

K180499,K180499

Product Code

NUJ

Product Code Name

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

Public Device Record Key

1bee198e-4964-4ffe-8842-bd49997cea45

Public Version Date

March 31, 2020

Public Version Number

3

DI Record Publish Date

March 06, 2020

Package DI Number

57613327504892

Quantity per Package

6

Contains DI Package

07613327504897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case