FDA.report

AVVIGO™ Guidance System II

Primary DI
00191506015169
Brand
AVVIGO™ Guidance System II
Company
BOSTON SCIENTIFIC CORPORATION
Model
H749009881CR0
Device description
Guidance System
Published
2021-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191506015169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506015169001915060151691915060151690191506015169

GMDN Terms

TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
00841517112561Sonosite PXFUJIFILM SONOSITE, INC.ITX2026-03-12
16975424198729Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.ITX2026-03-11
04987670102721PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102745LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102752LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102769PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102783LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102806CW DOPPLER PENCIL TRANSDUCERCANON INC.ITX2026-03-01
04987670102820CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102837ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102844LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102851ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102868ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102875CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102882CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670106507DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106514DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106521DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
10885632426711HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426728HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426735HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426742HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426759HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426766HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426773HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426780HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426797HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11