VOLNEWMER F tip(D)

GUDID 08800016905427

CLASSYS Inc.

Radio-frequency skin contouring system applicator tip
Primary Device ID08800016905427
NIH Device Record Keybf938217-df98-4221-bb69-82b76df9c117
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOLNEWMER F tip(D)
Version Model NumberVLMC03002D
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 Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800016905427 [Primary]

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 Date2025-06-24
Device Publish Date2025-06-16

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
08800016905427 - VOLNEWMER F tip(D)2025-06-24
08800016905434 - VOLNEWMER I tip(D)2025-06-24

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