Catalog Number

SU1101

Brand Name

Medovations®

Version/Model Number

SU1101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

fb3fc553-240a-46f1-bb0b-919d292de264

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

September 17, 2016

Package DI Number

M783SU11011

Quantity per Package

10

Contains DI Package

M783SU11010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case