Quanta forte

GUDID 08033945934668

QUANTA SYSTEM SPA

Multi-modality skin surface treatment system generator
Primary Device ID08033945934668
NIH Device Record Keyc94e8d83-a35c-4899-892d-c2aea6af7f60
Commercial Distribution Discontinuation2018-11-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameQuanta forte
Version Model NumberPZMS00012
Company DUNS436045833
Company NameQUANTA SYSTEM SPA
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 Datetrue
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
GS108033945934668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-01
Device Publish Date2016-08-18

On-Brand Devices [Quanta forte]

08033945934750PZMS00013
08033945934668PZMS00012
08033945934651PZMS00011

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