Catalog Number

M714

Brand Name

MEDADV

Version/Model Number

M714

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)

Yes

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

K063757,K063757

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

8df4eeff-03f8-44ca-94ca-e131d99b3bd2

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

March 01, 2018

Package DI Number

20819667020092

Quantity per Package

6

Contains DI Package

10819667020095

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-