FDA.reportPublic FDA data

EmboCube®

Primary DI
00884450306239
Brand
EmboCube®
Company
BIOSPHERE MEDICAL
Model
Initial Release
Catalog number
EC5050
Published
2026-01-15
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

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450306236PackageGS15In Commercial Distribution
00884450306239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445030623610884450306236
00884450306239008844503062398844503062390884450306239

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, animal-derivedA bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

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
00884450306246EmboCube®Initial ReleaseEC501002026-01-15
00884450408810Torpedo™Initial ReleaseTOR25102026-01-15
00884450408834Torpedo™Initial ReleaseTOR25202026-01-15
00884450408858Torpedo™Initial ReleaseTOR50102026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886704080121GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080138GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080145GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080152GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080206GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080213GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077046DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077077DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077176DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077183DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077299DELTAXSFTCerenovus, Inc.KRD2016-11-16
10886704077374DELTAXSFTCerenovus, Inc.KRD2016-11-16
10886704076933DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076940DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077091DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077114DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077121DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077138DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077145DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077152DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077169DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077190DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077213MICRUSFRAMECerenovus, Inc.KRD2016-11-16
10886704077220DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077237DELTAFILLCerenovus, Inc.KRD2016-11-16