Catalog Number

84-14-2800

Brand Name

ZEOS

Version/Model Number

84-14-2800

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

HRX

Product Code Name

Arthroscope

Public Device Record Key

be00ba39-2aeb-4485-8ba6-8d7f4e2d9aaf

Public Version Date

January 03, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2018

Package DI Number

00812231031551

Quantity per Package

1

Contains DI Package

00812231030936

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

REPAIR-REPLACE