FDA.reportPublic FDA data

star RF Electrode

Primary DI
28809306760023
Brand
star RF Electrode
Company
STARMED CO.,LTD
Model
17-15s30F
Catalog number
17-15s30F
Device description
The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
Published
2017-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K163450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163450000VIVA combo RF SystemStarmed Co., Ltd.2017-03-08GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809306760026PackageGS15In Commercial Distribution
28809306760023PackageGS110In Commercial Distribution
08809306760029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880930676002618809306760026
2880930676002328809306760023
08809306760029088093067600298809306760029

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous electrosurgical probe, tumour-ablation, monopolarA sterile, semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter
Needle Gauge17Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82318163546inquiry@starmed4u.com

Regulatory Flags#

DUNS number
694699723
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809306764072VIVA RF Electrode19-05V05-15X_V22026-06-04
08809306764089VIVA RF Electrode18-07V05-15X_V22026-06-04
08809306764133VIVA RF Electrode19-07V05-15X_V22026-06-04
08809306764140VIVA RF Electrode19-08V05-15X_V22026-06-04
08809306764157VIVA RF Electrode19-10V05-15X_V22026-06-04
08809306764164VIVA RF Electrode18-05V05-15X_V22026-06-04
08809306764171VIVA RF Electrode18-08V05-15X_V22026-06-04
08809306764188VIVA RF Electrode18-10V05-15X_V22026-06-04
08809306769251TS-RF GeneratorSTS102025-12-01
08809306769244VVR GeneratorVVR102024-09-30
08809306764010VENISTAR7-VENI007090N2024-08-29
08809306764874VENISTAR3-VENI003090N2024-08-29
08809306767868VENISTAR3-VENI0030N2024-08-29
08809306767875VENISTAR7-VENI0070N2024-08-29
18809306764017VENISTAR7-VENI007090N2024-08-29
18809306764871VENISTAR3-VENI003090N2024-08-29
18809306767865VENISTAR3-VENI0030N2024-08-29
18809306767872VENISTAR7-VENI0070N2024-08-29
08809922260637ELRA Electrode7-2B11L2024-08-28
18809922260634ELRA Electrode7-2B11L2024-08-28

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