Catalog Number

-

Brand Name

StitchKit

Version/Model Number

SK-002

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

K123811,K123811

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

4e2efc2a-6c51-4629-8754-39115cca344f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2015

Package DI Number

00860088000213

Quantity per Package

6

Contains DI Package

00860088000206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box