FDA.reportPublic FDA data

VENISTAR

Primary DI
18809306767872
Brand
VENISTAR
Company
STARMED CO.,LTD
Model
7-VENI0070N
Published
2024-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K222997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222997000VVR Generator systemStarmed Co., Ltd.2023-10-25GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809306767872PackageGS15In Commercial Distribution
28809306767879PackageGS110In Commercial Distribution
08809306767875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880930676787218809306767872
2880930676787928809306767879
08809306767875088093067678758809306767875

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular radio-frequency ablation catheterA sterile, rigid, hand-held luminal device intended to be percutaneously introduced into the peripheral vasculature as the distal component of a radio-frequency ablation system, to deliver radio-frequency current, in a bipolar configuration, for ablation of venous tissue to treat venous reflux disease (varicose veins). It typically includes an inner trocar/stylet to assist introduction and is maneuvered under external image guidance [e.g., ultrasound (US)]. This is a single-use device.

Sterilization Methods#

Method table
Method

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
08809922260637ELRA Electrode7-2B11L2024-08-28
18809922260634ELRA Electrode7-2B11L2024-08-28
08809922260620ELRA Electrode7-2B11S2023-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21