Catalog Number

-

Brand Name

IMEDICOM SAW BLADE

Version/Model Number

KLM-920A

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)

-

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

1cc25356-a519-4012-9c18-0e19e694a113

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

July 13, 2018

Package DI Number

08800038018884

Quantity per Package

10

Contains DI Package

08809317173634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-