FDA.reportPublic FDA data

OptiCross

Primary DI
08714729841531
Brand
OptiCross
Company
BOSTON SCIENTIFIC CORPORATION
Model
H749518120
Device description
40 MHz Coronary Imaging Catheter
Published
2016-09-24
Public version status
Update
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
OBJCatheter, ultrasound, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729841531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729841531087147298415318714729841531

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, single-useA 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 either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975345061102Disposable Intracardiac Echocardiography CatheterJiangsu Tingsn Technology Co., Ltd.OBJ2026-01-31
00884838112988Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
04056869957708AcuNav CRYSTAL G Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-11-21
05415067053190ViewFlex™IRVINE BIOMEDICAL, INC.OBJ2025-11-21
00845225003319Visions PV .014P RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003364Eagle Eye Platinum RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003371Eagle Eye Platinum ST RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
10841716103602ACIST Kodama® Coronary Imaging CatheterACIST MEDICAL SYSTEMS, INC.OBJ2025-08-14
10846835026559NUVISION NAV Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
10846835026566NUVISION Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
00884838126893EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126909Affiniti CVx Diagnostic Ultrasound System Philips Ultrasound LLCOBJ2025-06-23
00884838126923EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126930EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126947Affiniti CVx Diagnostic Ultrasound System Circular EditionPhilips Ultrasound LLCOBJ2025-06-23
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-19
00845225012854ICE PIMPhilips Image Guided Therapy CorporationOBJ2025-03-24
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
57613327664091Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
57613327664107Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
04056869281483AcuNav Crystal Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-01-03