Catalog Number

84-10-2300

Brand Name

ZEOS

Version/Model Number

84-10-2300

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

b2564176-a932-4368-8b41-f5c074265582

Public Version Date

August 31, 2018

Public Version Number

2

DI Record Publish Date

June 29, 2018

Package DI Number

00812231030523

Quantity per Package

1

Contains DI Package

00812231030028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner