EndyMed Pure 85W system 220V ND_PRD00088-01

GUDID 07290016814293

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 Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system
Primary Device ID07290016814293
NIH Device Record Keye01aa8f7-9574-4a7d-8968-49f8f87086ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed Pure 85W system 220V
Version Model NumberPure 85W system 220V
Catalog NumberND_PRD00088-01
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
GS107290016814293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

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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07290016814415 - endyMed PRO MAX, Intensif MAX Handpiece2024-05-24 The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis
07290016814422 - EndyMed PRO MAX, Small 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
07290016814439 - EndyMed PRO MAX, FSR 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
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
07290016814477 - EndyMed PRO MAX, Contour MAX Handpiece2024-05-24 The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator fo

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