Catalog Number

84-10-1400

Brand Name

ZEOS

Version/Model Number

84-10-1400

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

1e9bf35a-4a6f-49a6-b04a-4c01d43db013

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

00812231031971

Quantity per Package

1

Contains DI Package

00812231031889

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner