Catalog Number

KM58096

Brand Name

KMEDIC

Version/Model Number

IPN015431

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

-

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

00d8eef0-b5f9-4b59-8d6c-308161e2c6c0

Public Version Date

January 18, 2021

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-