Catalog Number

85-10-4100

Brand Name

Pixa

Version/Model Number

85-10-4100

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

f613d493-875e-41e6-a1cd-94c9226046c8

Public Version Date

February 22, 2019

Public Version Number

4

DI Record Publish Date

March 05, 2018

Package DI Number

00853460007375

Quantity per Package

1

Contains DI Package

00853460007245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Service