Catalog Number

-

Brand Name

ZEUS-P

Version/Model Number

65-260914

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FDA

Product Code Name

Enteroscope And Accessories

Public Device Record Key

8caadb27-44b8-4c95-946b-a0da1f1f9795

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

August 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-