Catalog Number

M004N0011

Brand Name

Maestro

Version/Model Number

1291H

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"

Yes

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

K203494,K203494

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

24e15c56-dddd-434e-8d67-d143fc780ef2

Public Version Date

February 04, 2022

Public Version Number

1

DI Record Publish Date

January 27, 2022

Package DI Number

35060441919992

Quantity per Package

25

Contains DI Package

15060441919998

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box