Catalog Number

84-20-50032

Brand Name

ZEOS

Version/Model Number

84-20-50032

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

FFY

Product Code Name

Adaptor, Bulbs, Miscellaneous, For Endoscope

Public Device Record Key

44a43dd3-5f88-450c-91f9-25cc8c0884d0

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-