VOLNEWMER F tip

GUDID 08800016902723

CLASSYS Inc.

Radio-frequency skin contouring system applicator tip
Primary Device ID08800016902723
NIH Device Record Keyf4a82797-59c3-460d-8ab4-1736bd51b63b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOLNEWMER F tip
Version Model NumberVLMC03001
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
GS108800016902723 [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 Date2024-08-12
Device Publish Date2024-08-03

Devices Manufactured by CLASSYS Inc.

08800016903287 - Secret RF Set Package2024-11-04
08800016902709 - VOLNEWMER S tip2024-08-12
08800016902716 - VOLNEWMER V tip2024-08-12
08800016902723 - VOLNEWMER F tip2024-08-12
08800016902723 - VOLNEWMER F tip2024-08-12
08800016902730 - VOLNEWMER I tip2024-08-12
18800016902751 - Grounding Plate2024-08-12
18800016902799 - Coupling Gel2024-08-12
08800016902945 - VOLNEWMER2024-08-12

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