Catalog Number

-

Brand Name

NA

Version/Model Number

0600127

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"

Yes

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

K123847,K123847,K123847

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

2f75452c-4ba2-4445-947a-9390354b6ee0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2016

Package DI Number

10815634020310

Quantity per Package

6

Contains DI Package

00815634020313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHELFL BOX