Catalog Number

-

Brand Name

AutoLap ARM

Version/Model Number

MST-02-0101

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 19, 2017

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

K131375,K152848,K131375,K152848

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

d31b0208-83dc-4cad-a023-4098f9b59a92

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

17290016648024

Quantity per Package

1

Contains DI Package

07290016648027

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

-