FDA.reportPublic FDA data

Endovenous Radiofrequency Ablation (RFA) Catheter

Primary DI
10860036000552
Brand
Endovenous Radiofrequency Ablation (RFA) Catheter
Company
Vein360 LLC
Model
VEN-7-100
Catalog number
VEN-7-100
Device description
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Published
2021-10-26
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
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860036000552PackageGS110In Commercial Distribution
08600360005008PreviousGS10
00860036000555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086003600055210860036000552
08600360005008086003600050088600360005008
00860036000555008600360005558600360005550860036000555

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

Regulatory Flags#

DUNS number
080926907
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
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
08600360005022Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-06-17
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
10860036000569Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850044399017NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2025-05-21
10888277408746MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
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10888277719392MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
B504AEAR98310ArthrexProvisionNUJ2024-09-17
B504CB1381050ConMedProvisionNUJ2024-07-01
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B504CBEN70000StrykerProvisionNUJ2024-05-22
00850043377009AquamantysGREEN OR LLCNUJ2024-05-16
00850043377016AquamantysGREEN OR LLCNUJ2024-05-16
00850043377023Aquamantys GREEN OR LLCNUJ2024-05-16
00850043377085AquamantysSTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2024-05-16