Catalog Number

84-20-5003

Brand Name

ZEOS

Version/Model Number

84-20-5003

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

FST

Product Code Name

Light, Surgical, Fiberoptic

Public Device Record Key

1673008b-2bdf-4e64-a208-c8aa03f2597b

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 30, 2018

Package DI Number

00812231030899

Quantity per Package

1

Contains DI Package

00812231030356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner