FDA.reportPublic FDA data

Contour™

Primary DI
08714729743965
Brand
Contour™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0017600150
Catalog number
M0017600150
Device description
Embolization Particles
Published
2015-09-24
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
NAJAGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAJAgents, Embolic, For Treatment Of Uterine FibroidsCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729159674PackageGS15In Commercial Distribution
08714729743965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729159674087147291596748714729159674
08714729743965087147297439658714729743965

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526613876LATITUDE® NXT646064602020-04-09
08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
08714729999577ROTAPRO™H749394671500H7493946715002020-07-01
08714729999584ROTAPRO™H749394671750H7493946717502020-07-01
08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
08714729999607ROTAPRO™H749394672150H7493946721502020-07-01
08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00191506062620RIVOS™M00553900M005539002026-06-25
08714729050650Entry KitM001503500M0015035002016-01-29
08714729082026SteeroCath-Dx™M0042028BL02016-09-24
08714729085249Electrophysiology CableM00490002016-09-24
08714729114659Greenfield™M001503000M0015030002015-09-24
08714729114666Greenfield™M001503010M0015030102015-09-24
08714729124993Greenfield™M001505010M0015050102015-09-24
08714729270249Electrophysiology CableM004901AS02016-09-24
08714729270256Electrophysiology CableM004901BS02016-09-24
08714729334996Electrophysiology CableM004921B02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810563021127Embozene Color Advance 700um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021134Embozene Color Advance 900um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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00810563021424ONCOZENE 40um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021431ONCOZENE 40um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021448ONCOZENE 75um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
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00810563021462ONCOZENE 100um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
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00810563021516Embozene Color Advance 250um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021523Embozene Color Advance 400um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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00810563021547Embozene Color Advance 700um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021554Embozene Color Advance 900um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021561Embozene Color Advance 1100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021578Embozene Color Advance 1300um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00884450403716Embosphere®BIOSPHERE MEDICALNAJ2022-10-01
00884450403822Embosphere®BIOSPHERE MEDICALNAJ2022-10-01
00884450299432Embosphere®BIOSPHERE MEDICALNAJ2022-09-20
10884450299439Embosphere®BIOSPHERE MEDICALNAJ2022-09-20