Catalog Number

179076P

Brand Name

Versaport Plus

Version/Model Number

179076P

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

0c4f6e58-8f52-4da5-bda3-f577cee4f0be

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10884521082649

Quantity per Package

3

Contains DI Package

20884521082646

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE