Secret DUO Standard Handpiece

GUDID 08800016904666

CLASSYS Inc.

Intradermal radio-frequency ablation system
Primary Device ID08800016904666
NIH Device Record Key5a1739c8-d8fc-4e9e-9c7a-d43e4d05d5cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecret DUO Standard Handpiece
Version Model NumberMTR3.0
Company DUNS689842183
Company NameCLASSYS 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS108800016904666 [Primary]
GS108800023200959 [Previous]

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 Date2024-11-07
Device Publish Date2024-10-30

Devices Manufactured by CLASSYS Inc.

08800016905366 - VOLNEWMER S tip2025-06-24
08800016905373 - VOLNEWMER V tip2025-06-24
08800016905380 - VOLNEWMER F tip2025-06-24
08800016905397 - VOLNEWMER I tip2025-06-24
08800016905403 - VOLNEWMER S tip(D)2025-06-24
08800016905410 - VOLNEWMER V tip(D)2025-06-24
08800016905427 - VOLNEWMER F tip(D)2025-06-24
08800016905434 - VOLNEWMER I tip(D)2025-06-24

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