Catalog Number

-

Brand Name

Laparoscopic Smoke Evacuator

Version/Model Number

LSE-01

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

-

Product Code

FCZ

Product Code Name

Tube, Smoke Removal, Endoscopic

Public Device Record Key

74c3b14b-e602-4ece-9540-3023f29e707f

Public Version Date

April 20, 2021

Public Version Number

1

DI Record Publish Date

April 12, 2021

Package DI Number

09349967004227

Quantity per Package

30

Contains DI Package

09349967004210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box