FDA.reportPublic FDA data

Microneedle electrodes

Primary DI
06976264730080
Brand
Microneedle electrodes
Company
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD
Model
25-Pin
Published
2023-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231749000Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.2023-10-19GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976264730080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976264730080069762647300806976264730080

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
706040997
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976264730028LED Spectrum therapy instrumentPDT-I2023-11-17
06976264730035LED Spectrum therapy instrumentPDT-J2023-11-17
06976264730042LED Spectrum therapy instrumentPDT-K2023-11-17
06976264730059LED Spectrum therapy instrumentPDT-L2023-11-17
06976264730066LED Spectrum therapy instrumentPDT-M2023-11-17
06976264730073Radio Frequency SystemRF-3012023-11-17
06976264730097Microneedle electrodes49-Pin2023-11-17
06976264730103RF electrodes49-RF2023-11-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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