Catalog Number

-

Brand Name

Versaport Plus

Version/Model Number

179074P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K954108,K954108

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

7d2eb9b2-df61-467c-b63c-6e8ea5926aad

Public Version Date

September 14, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521082670

Quantity per Package

3

Contains DI Package

20884521082677

Package Discontinue Date

April 22, 2022

Package Status

Not in Commercial Distribution

Package Type

CASE