FDA.reportPublic FDA data

Endovenous Radiofrequency Ablation (RFA) Catheter

Primary DI
08600360005022
Brand
Endovenous Radiofrequency Ablation (RFA) Catheter
Company
Vein360 LLC
Model
VEN-3-60
Catalog number
VEN-3-60
Device description
Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Published
2021-06-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08600360005022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600360005022086003600050228600360005022

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5138540239tfister@vein360.com

Regulatory Flags#

DUNS number
080926907
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
00850065047003Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)014RRH014RRH2024-08-02
00850065047010Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .01886700RH86700RH2024-08-02
00850065047027Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter88901RH88901RH2024-08-02
00850065047034Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)85910PRH85910PRH2024-08-02
00850065047041Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter85900PRH85900PRH2024-08-02
00850065047058Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter 85900PSTRH85900PSTRH2024-08-02
00860036000517Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)VEN-PV-014RVEN-PV-014R2024-03-25
00860036000579Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)VEN-PV-014PVEN-PV-014P2024-03-25
00860036000586Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS CatheterVEN-PV-EEPVEN-PV-EEP2024-03-25
00860036000593Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS CatheterVEN-PV-EEPSTVEN-PV-EEPST2024-03-25
08600360005008Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-100VEN-7-1002021-06-17
08600360005107Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-60VEN-7-602021-06-17
00860036000524Reprocessed Visions PV.018 Digital IVUS CatheterVEN-PV-018VEN-PV-0182023-09-29
00860036000531Reprocessed Visions PV.035 Digital IVUS CatheterVEN-PV-035VEN-PV-0352023-08-29
00860036000548Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-60VEN-7-602021-10-26
00860036000555Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-100VEN-7-1002021-10-26
00860036000562Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-10-26
10860036000545Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-60VEN-7-602021-10-26
10860036000552Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-100VEN-7-1002021-10-26
10860036000569Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-10-26

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