Catalog Number

KM42825P

Brand Name

KMEDIC

Version/Model Number

IPN013463

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

GAH

Product Code Name

STYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

102e09cf-0e73-49a8-b1d9-207c19b5cd47

Public Version Date

December 16, 2019

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

-