EndyMed PRO Intensif Handpiece ND_PRD00185

GUDID 07290016814200

The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis

ENDYMED MEDICAL LTD

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Primary Device ID07290016814200
NIH Device Record Key9c9fe5b9-56a7-4549-8e7d-cd4d7a6de2b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed PRO Intensif Handpiece
Version Model NumberIntesif Handpiece
Catalog NumberND_PRD00185
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
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814200 [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 Date2018-12-31

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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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