Catalog Number

-

Brand Name

SHAVER BLADE, T/A MALLEABLE, MONOPOLAR DIEGO ELITE

Version/Model Number

MM4000SS

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

K123429,K123429

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

d34e0758-1bac-470d-a430-62615f490231

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 14, 2016

Package DI Number

00821925027978

Quantity per Package

5

Contains DI Package

00821925038530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-