Catalog Number

179078P

Brand Name

Versaport Plus

Version/Model Number

179078P

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

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

df30ae4b-240b-4555-8cfc-89a49dd8222d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10884521082663

Quantity per Package

3

Contains DI Package

20884521082660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE