FDA.reportPublic FDA data

Embosphere®

Primary DI
00884450299432
Brand
Embosphere®
Company
BIOSPHERE MEDICAL
Model
00884450299432
Catalog number
S020GH/A
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10884450299439PackageGS15In Commercial Distribution
00884450299432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445029943910884450299439
00884450299432008844502994328844502994320884450299432

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.

Device Sizes#

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

Regulatory Flags#

DUNS number
635091932
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450402948Embosphere®00884450402948S020GH/C2019-10-31
00884450403051Embosphere®00884450403051S1010GH/C2019-12-02
00884450403136Embosphere®00884450403136S1020GH/C2019-09-10
00884450403150Embosphere®00884450403150S120GH/C2019-03-25
00884450403174Embosphere®00884450403174S210GH/C2019-03-13
00884450403204Embosphere®00884450403204S220GH/C2019-03-25
00884450403402Embosphere®00884450403402S410GH/C2019-03-29
00884450403426Embosphere®00884450403426S420GH/C2019-06-17
00884450403433Embosphere®00884450403433S610GH/C2019-03-29
00884450403440Embosphere®00884450403440S620GH/C2019-03-08
00884450403457Embosphere®00884450403457S810GH/C2019-04-09
00884450403464Embosphere®00884450403464S820GH/C2019-03-08
00884450403716Embosphere®00884450403716V220GH/B2022-10-01
00884450403822Embosphere®00884450403822V610GH/B2022-10-01
00884450306208EmboCube®Initial ReleaseEC25502026-01-15
00884450306215EmboCube®Initial ReleaseEC251002026-01-15
00884450306239EmboCube®Initial ReleaseEC50502026-01-15
00884450306246EmboCube®Initial ReleaseEC501002026-01-15
00884450408810Torpedo™Initial ReleaseTOR25102026-01-15
00884450408834Torpedo™Initial ReleaseTOR25202026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810563021066Embozene Color Advance 40um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021073Embozene Color Advance 75um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021080Embozene Color Advance 100um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021097Embozene Color Advance 250um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021103Embozene Color Advance 400um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021110Embozene Color Advance 500um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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
00810563021141Embozene Color Advance 1100um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021158Embozene Color Advance 1300um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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
00810563021455ONCOZENE 75um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021462ONCOZENE 100um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021479ONCOZENE 100um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021486Embozene Color Advance 40um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021493Embozene Color Advance 75um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021509Embozene Color Advance 100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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
00810563021530Embozene Color Advance 500um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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
10884450299439Embosphere®BIOSPHERE MEDICALNAJ2022-09-20
00191506011345Bead Block™BOSTON SCIENTIFIC CORPORATIONNAJ2021-10-14