Catalog Number

N21-1110

Brand Name

Laport

Version/Model Number

N21-1110

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

0556adac-1d3a-4c83-90b1-cbbaf404a194

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

April 05, 2018

Package DI Number

18806182210430

Quantity per Package

10

Contains DI Package

08806182210433

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INBOX