Catalog Number

N21-0575

Brand Name

Laport

Version/Model Number

N21-0575

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

K171741,K171741,K171741

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

49ae77e9-b6d1-45d3-98a6-796d0f15493a

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

April 05, 2018

Package DI Number

88806182210392

Quantity per Package

8

Contains DI Package

18806182210393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON