EndyMed PRO Contour Handpiece ND_PRD00180

GUDID 07290016814088

The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-ther

ENDYMED MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290016814088
NIH Device Record Key6827e4c0-b997-48ae-98a0-ca6a90d9a01c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed PRO Contour Handpiece
Version Model NumberCountour Handpiece
Catalog NumberND_PRD00180
Company DUNS531958689
Company NameENDYMED MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-363-9633
Emailservice@endymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814088 [Primary]

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-21
Device Publish Date2018-12-31

Devices Manufactured by ENDYMED MEDICAL LTD

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17290014660110 - NEWA PLUS Kit2022-01-17 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
07290014660083 - NEWA Kit2021-10-01 The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles
17290014660028 - NEWA PLUS Kit2021-05-06 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
07290014660014 - NEWA PLUS Kit2021-04-28 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin

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