Zaffiro System 100-1100

GUDID 00850017374089

Zaffiro is a state-of-the-art instrument designed to deep clean, resurface and nourish skin and perform a non-invasive, thermo-lifting.

NEAUVIA NORTH AMERICA, INC.

Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary Dermabrasion brush, rotary
Primary Device ID00850017374089
NIH Device Record Keye8fdc127-ec81-4e5d-9975-0ab6667c1753
Commercial Distribution StatusIn Commercial Distribution
Brand NameZaffiro System
Version Model NumberZ200NG
Catalog Number100-1100
Company DUNS117030786
Company NameNEAUVIA NORTH AMERICA, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5292
Emailmisty@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com
Phone984-777-5296
Emailjoy@neauvia-us.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017374089 [Primary]

FDA Product Code

GFEBrush, Dermabrasion, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-22
Device Publish Date2020-09-14

Devices Manufactured by NEAUVIA NORTH AMERICA, INC.

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00850017374218 - EpilMe Applicator2022-10-11 Handpiece applicator for EpilMe System
00850017374126 - Sectum System2021-10-05
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00850017374140 - Sectum Body Applicator2021-10-05
00850017374157 - Sectum Foot Switch2021-10-05 Foot switch for the Sectum System
00850017374164 - Sectum Cable Body Applicator2021-10-05

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