Sectum Cable Precise (Face) Applicator

GUDID 00850017374171

NEAUVIA NORTH AMERICA, INC.

Radio-frequency skin contouring system
Primary Device ID00850017374171
NIH Device Record Keybd023e10-f217-495c-b5f3-1bbbb57176ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameSectum Cable Precise (Face) Applicator
Version Model Number300-1310
Company DUNS117030786
Company NameNEAUVIA NORTH AMERICA, INC.
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
GS100850017374171 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-05
Device Publish Date2021-09-27

Devices Manufactured by NEAUVIA NORTH AMERICA, INC.

00850017374188 - LaserMe2023-08-23 The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedure
00850017374201 - EpilMe System2022-10-11 Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of gen
00850017374218 - EpilMe Applicator2022-10-11 Handpiece applicator for EpilMe System
00850017374126 - Sectum System2021-10-05
00850017374133 - Sectum Precise (Face) Applicator2021-10-05
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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