EndyMed PRO 85W System 110V - The EndyMed Pro System is a noninvasive device - ENDYMED MEDICAL LTD

Duns Number:531958689

Device Description: The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and Genera The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides

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More Product Details

Catalog Number

ND_PRD00006_F

Brand Name

EndyMed PRO 85W System 110V

Version/Model Number

PRO 85W System 110V

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083461

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

9c9f8321-b3e4-496f-92ff-97b6443f5ab2

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

March 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENDYMED MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32