Catalog Number

84-10-4310

Brand Name

ZEOS

Version/Model Number

84-10-4310

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

8e8c4ec5-58b8-46a0-9283-1116f0176fc8

Public Version Date

February 24, 2021

Public Version Number

2

DI Record Publish Date

December 12, 2019

Package DI Number

00812231031919

Quantity per Package

1

Contains DI Package

00812231031865

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner