Catalog Number

-

Brand Name

Kirwan

Version/Model Number

40-1000

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

K861876,K861876

Product Code

GFA

Product Code Name

Blade, Saw, General & Plastic Surgery, Surgical

Public Device Record Key

4e2bf69b-ace8-48e8-9302-f7707b3b71a4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2016

Package DI Number

10841019107697

Quantity per Package

5

Contains DI Package

00841019107690

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-