FDA.reportPublic FDA data

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Primary DI
B227ARJ5100
Brand
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Company
NORTH EAST SCIENTIFIC INC
Model
R-85900P
Published
2023-07-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWQReprocessed Intravascular Ultrasound Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWQReprocessed Intravascular Ultrasound CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223026000NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.2023-02-03OWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B227ARJ5100PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length150Centimeter
Guidewire Diameter0.014Inch
Introducer Sheath Compatibilit5French

Contacts#

Phone, Email table
PhoneEmail
203-756-2111info@smarthealth-care.com

Regulatory Flags#

DUNS number
608625823
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B227RS014R1NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2024-08-15
00850044399000NES Reprocessed Varicose Vein RF CatheterCF7-7-60R-CF7-7-602025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterCF7-7-100R-CF7-7-1002025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterCF7-3-60R-CF7-3-602025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)R-RFS2-6-12R-RFS2-6-122025-05-21
00850044399048EsoSure1000011000012025-05-21
00850044399055NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterR-410-152R-410-1522025-05-21
00850044399062NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterR-410-154R-410-1542025-05-21
00850044399079NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterR-420-006R-420-0062025-05-21
00850044399086NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterR-420-159R-420-1592025-05-21
00850044399093NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterR-417-152R-417-1522025-05-21
00850044399109NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterR-417-156R-417-1562025-05-21
00850044399116NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterR-414-151R-414-1512025-05-21
00850044399123NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterR-414-159R-414-1592025-05-21
00850044399130NES Reprocessed Visions PV .035 Digital IVUS CatheterR-88901R-889012025-05-21
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterR-014RR-014R2025-05-21
00850044399154NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterR-85900P2025-05-21
00850044399161NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short TipR-85900PST2025-05-21
00850044399208NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2025-05-21
00850044399215NES Reprocessed Eagle Eye Platinum Long Tip StrykerR-S85900PR-S85900P2025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B227R85900PST1NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2024-08-15
B227RS014R1NES Reprocessed .014 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2024-08-15