Catalog Number

-

Brand Name

Macan

Version/Model Number

R-L41

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052622,K052622

Product Code

EKZ

Product Code Name

Unit, Electrosurgical, And Accessories, Dental

Public Device Record Key

a7410a87-0ffa-4f67-9b3f-2be41c7c7f48

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-