VOLNEWMER Arm Stand A

GUDID 08800016902952

CLASSYS Inc.

Radio-frequency skin contouring system applicator, monopolar
Primary Device ID08800016902952
NIH Device Record Key244b1022-6d5d-4262-98ed-74b4dfe0ae76
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOLNEWMER Arm Stand A
Version Model NumberVLMHPA001
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
GS108800016902952 [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
08800016902730 - VOLNEWMER I tip2024-08-12
18800016902751 - Grounding Plate2024-08-12
18800016902799 - Coupling Gel2024-08-12
08800016902945 - VOLNEWMER2024-08-12

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