Macan - Flexible Dispersive Plate only, plastic coated 7" - Macan Manufacturing

Duns Number:962296062

Device Description: Flexible Dispersive Plate only, plastic coated 7" x 11", not autoclaveable

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More Product Details

Catalog Number

-

Brand Name

Macan

Version/Model Number

FDP-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K050735

Product Code Details

Product Code

EKZ

Product Code Name

Unit, Electrosurgical, And Accessories, Dental

Device Record Status

Public Device Record Key

f3c253aa-7880-4e2e-a1c7-2de0e2a71020

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MACAN MANUFACTURING" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33