Catalog Number

8023S

Brand Name

N/A

Version/Model Number

8023S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2017

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

K914919

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

eb0f9a36-299a-4bc9-b7d8-92a17bc552a5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-