Catalog Number

-

Brand Name

EVA15

Version/Model Number

LAP300

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"

-

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

K202799,K202799

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

a26b477f-742f-4f32-9a7c-0c9e6cb0fa51

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 11, 2020

Package DI Number

05391536920012

Quantity per Package

10

Contains DI Package

05391536920005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box