Catalog Number

84-12-3102

Brand Name

ZEOS

Version/Model Number

84-12-3102

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

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

659e0bb9-8c19-484e-a0ba-dd8908c1cafd

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

July 27, 2018

Package DI Number

00812231030547

Quantity per Package

1

Contains DI Package

00812231030226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner