FDA.reportPublic FDA data

Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter

Primary DI
00860036000586
Brand
Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter
Company
Vein360 LLC
Model
VEN-PV-EEP
Catalog number
VEN-PV-EEP
Device description
Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OWQReprocessed Intravascular Ultrasound Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWQReprocessed Intravascular Ultrasound CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860036000586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860036000586008600360005868600360005860860036000586

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, reprocessedA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080926907
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
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
10860036000552Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-100VEN-7-1002021-10-26
10860036000569Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898137273N/AINNOVATIVE HEALTH LLCOWQ2026-06-01
10841898137280N/AINNOVATIVE HEALTH LLCOWQ2026-06-01
10841898137174N/AINNOVATIVE HEALTH LLCOWQ2026-05-07
10841898137266N/AINNOVATIVE HEALTH LLCOWQ2026-05-07
10197344019557MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344026500MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344026517MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344149537MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
10197344149544MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
10197344157303MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-11
10197344157280MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
10197344157273MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
20197344157287MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
10197344157297MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
00850044399130NES Reprocessed Visions PV .035 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399154NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399161NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short TipNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399208NES Reprocessed .014 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399215NES Reprocessed Eagle Eye Platinum Long Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-19
07613327664089Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
57613327664114Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
10841898134494N/AINNOVATIVE HEALTH LLCOWQ2024-11-06
B227RS889011NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2024-08-16