EndyMed PRO 85W System Body 110V ND_PRD00006_F_B

GUDID 07290016814163

The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mil

ENDYMED MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290016814163
NIH Device Record Key06780dd5-569c-4258-a502-29ccb0206c01
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed PRO 85W System Body 110V
Version Model NumberPRO 85W System Body 110V
Catalog NumberND_PRD00006_F_B
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814163 [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

07290016814408 - EndyMed PRO MAX, System, 110V2024-05-24 The EndyMed PRO MAX System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-
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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