FDA.reportPublic FDA data

Embosphere Pro™

Primary DI
10884450299446
Brand
Embosphere Pro™
Company
BIOSPHERE MEDICAL
Model
00884450299449
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NOYAgents, embolic, for treatment of benign prostatic hyperplasia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOYAgents, Embolic, For Treatment Of Benign Prostatic HyperplasiaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160040000Embosphere MicrospheresBiosphere Medical, S.A.2017-06-21NOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450299446PackageGS110In Commercial Distribution
00884450299449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445029944610884450299446
00884450299449008844502994498844502994490884450299449

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA sterile, 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
635091932
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 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.NOY2023-05-19
00810563021073Embozene Color Advance 75um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021080Embozene Color Advance 100um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021097Embozene Color Advance 250um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021103Embozene Color Advance 400um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021110Embozene Color Advance 500um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021127Embozene Color Advance 700um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021134Embozene Color Advance 900um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021141Embozene Color Advance 1100um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021158Embozene Color Advance 1300um Embozene 2mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021486Embozene Color Advance 40um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021493Embozene Color Advance 75um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021509Embozene Color Advance 100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021516Embozene Color Advance 250um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021523Embozene Color Advance 400um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021530Embozene Color Advance 500um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021547Embozene Color Advance 700um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021554Embozene Color Advance 900um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021561Embozene Color Advance 1100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00810563021578Embozene Color Advance 1300um Embozene 1mL Colored - USVarian Medical Systems, Inc.NOY2023-05-19
00884450403716Embosphere®BIOSPHERE MEDICALNOY2022-10-01
00884450403822Embosphere®BIOSPHERE MEDICALNOY2022-10-01
00191506011345Bead Block™BOSTON SCIENTIFIC CORPORATIONNOY2021-10-14
00191506011352Bead Block™BOSTON SCIENTIFIC CORPORATIONNOY2021-10-14
00191506011369Bead Block™BOSTON SCIENTIFIC CORPORATIONNOY2021-10-14
00191506011376Bead Block™BOSTON SCIENTIFIC CORPORATIONNOY2021-10-14
00191506011383Bead Block™BOSTON SCIENTIFIC CORPORATIONNOY2021-10-14
00884450403051Embosphere®BIOSPHERE MEDICALNOY2019-12-02
00884450402948Embosphere®BIOSPHERE MEDICALNOY2019-10-31
00884450403136Embosphere®BIOSPHERE MEDICALNOY2019-09-10