Catalog Number

-

Brand Name

AutoLap Positioner

Version/Model Number

MST-13-0114

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

-

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

ba030dfb-9c95-47d8-a240-91535414e27f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

17290016648048

Quantity per Package

1

Contains DI Package

07290016648041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-