Catalog Number

KMS2213.17F.

Brand Name

KMS Blade

Version/Model Number

KMS2213.17F.YJ

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

-

Product Code

GFA

Product Code Name

Blade, Saw, General & Plastic Surgery, Surgical

Public Device Record Key

e63bb4ef-4091-4642-a2d6-3d06497f1593

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

Package DI Number

24053613285319

Quantity per Package

1

Contains DI Package

14053613285312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-