Radio Frequency System

GUDID 06976264730073

SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD

Percutaneous radio-frequency ablation system generator
Primary Device ID06976264730073
NIH Device Record Key9e17f6df-1061-4e39-bbe6-8ec0ba72bfc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadio Frequency System
Version Model NumberRF-301
Company DUNS706040997
Company NameSHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD
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 Batchfalse
Serial Numbertrue
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
GS106976264730073 [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 Date2023-11-27
Device Publish Date2023-11-17

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06976264730066 - LED Spectrum therapy instrument2023-11-27
06976264730073 - Radio Frequency System2023-11-27
06976264730073 - Radio Frequency System2023-11-27
06976264730080 - Microneedle electrodes2023-11-27
06976264730097 - Microneedle electrodes2023-11-27

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