EndyMed Pure system 220V ND_PRD00077

GUDID 07290016814286

The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.

ENDYMED MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290016814286
NIH Device Record Key8722d65e-28ac-4001-ae79-b3e8cfa0a392
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed Pure system 220V
Version Model NumberPure system 220V
Catalog NumberND_PRD00077
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 Datetrue
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
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUHSkin Resurfacing Rf Applicator

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 Date2019-03-03

Devices Manufactured by ENDYMED MEDICAL LTD

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07290016814446 - EndyMed PRO MAX, iFine MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814453 - EndyMed PRO MAX,Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814460 - EndyMed PRO MAX,Mini Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologi
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