Primary Device ID | 00850017374065 |
NIH Device Record Key | 0ae2ba00-ca62-45f7-8781-4f1abcecaf3e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Zaffiro IR Treatment Applicator |
Version Model Number | ZIR |
Catalog Number | 300-1104 |
Company DUNS | 117030786 |
Company Name | NEAUVIA NORTH AMERICA, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5292 |
misty@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com | |
Phone | 984-777-5296 |
joy@neauvia-us.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850017374065 [Primary] |
GFE | Brush, Dermabrasion, Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-22 |
Device Publish Date | 2020-09-14 |
00850017374188 - LaserMe | 2023-08-23 The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedure |
00850017374201 - EpilMe System | 2022-10-11 Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of gen |
00850017374218 - EpilMe Applicator | 2022-10-11 Handpiece applicator for EpilMe System |
00850017374126 - Sectum System | 2021-10-05 |
00850017374133 - Sectum Precise (Face) Applicator | 2021-10-05 |
00850017374140 - Sectum Body Applicator | 2021-10-05 |
00850017374157 - Sectum Foot Switch | 2021-10-05 Foot switch for the Sectum System |
00850017374164 - Sectum Cable Body Applicator | 2021-10-05 |