Catalog Number

-

Brand Name

Kirwan

Version/Model Number

40-1001

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

ecee33f5-b677-4a16-bddc-ec234b417051

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2016

Package DI Number

10841019107703

Quantity per Package

5

Contains DI Package

00841019107706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-