Virtue RF Microneedle Cartridge

GUDID 08800017100722

shenb Co., Ltd.

Radio-frequency skin surface treatment system
Primary Device ID08800017100722
NIH Device Record Key5f7aa95e-56e1-4f1a-921e-743f25aeaf7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVirtue RF Microneedle Cartridge
Version Model NumberSmartRF 36PIN TIP
Company DUNS690425442
Company Nameshenb Co., Ltd.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800017100722 [Primary]
GS108800017100739 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUHSkin Resurfacing Rf Applicator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-18
Device Publish Date2020-12-10

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