Catalog Number

IV-ASY-0450

Brand Name

MIDASystem™

Version/Model Number

IV-ASY-0450

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

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

-

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

K181982

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

dbfebcf3-0055-47a4-8097-2c29848be082

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

January 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-