Catalog Number

-

Brand Name

Versaport

Version/Model Number

177991

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

K963115,K963115

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

75896d72-68a7-448b-a317-0139c22172eb

Public Version Date

September 14, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884521093591

Quantity per Package

3

Contains DI Package

20884521093598

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE