SRA applicator FG70621R

GUDID 07290109951638

SRA Applicator, elos Plus

SYNERON MEDICAL LTD

Multi-modality skin surface treatment system
Primary Device ID07290109951638
NIH Device Record Key723cab4e-5e3c-4f61-9b5e-b6b5520ef386
Commercial Distribution StatusIn Commercial Distribution
Brand NameSRA applicator
Version Model NumberFG70621R
Catalog NumberFG70621R
Company DUNS532685716
Company NameSYNERON 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109951638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-25

On-Brand Devices [SRA applicator]

07290109951638SRA Applicator, elos Plus
07290109951331Elos-SR Advanced Applicator
07290109950891SRA Applicator, elos Plus
07290109950051Elos-SR Advanced Applicator

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