EndyMed Pro iFine Handpiece ND_PRD00036

GUDID 07290016814132

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

ENDYMED MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290016814132
NIH Device Record Key3c575a1d-d0de-485b-a4a4-d3b9aaaabd22
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed Pro iFine Handpiece
Version Model NumberPro iFine Handpiece
Catalog NumberND_PRD00036
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814132 [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 Number3
Public Version Date2019-03-21
Device Publish Date2018-12-31

Devices Manufactured by ENDYMED MEDICAL LTD

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