EndyMed Pure mini-shaper Handpiece ND_PRD00178

GUDID 07290016814057

The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical pr

ENDYMED MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290016814057
NIH Device Record Key0c8b74e4-193c-4609-b94f-496a30629b70
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed Pure mini-shaper Handpiece
Version Model Numbermini-shaper Handpiece
Catalog NumberND_PRD00178
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
GS107290016814057 [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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