Catalog Number

-

Brand Name

Pixa

Version/Model Number

85-10-4130

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

ba30ebc2-e8ec-43fb-a6ab-7d9ca3729e21

Public Version Date

February 22, 2019

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

00853460007382

Quantity per Package

1

Contains DI Package

00853460007269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Service