Catalog Number

EVA15

Brand Name

EVA15

Version/Model Number

EVA15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

cd5e0077-11cd-4179-a4ed-49225d1eac62

Public Version Date

November 19, 2020

Public Version Number

1

DI Record Publish Date

November 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-