Catalog Number

84-10-2220

Brand Name

ZEOS

Version/Model Number

84-10-2220

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

FEM

Product Code Name

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Public Device Record Key

3eb0d219-dea2-4fdf-866d-c8c8b47c1929

Public Version Date

March 19, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2019

Package DI Number

00812231031858

Quantity per Package

1

Contains DI Package

00812231031605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner