FDA.reportPublic FDA data

Bead Block™

Primary DI
00191506011376
Brand
Bead Block™
Company
BOSTON SCIENTIFIC CORPORATION
Model
EB2S709-US
Catalog number
EB2S709-US
Device description
Bland Embolic Bead
Published
2021-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
KRDDevice, Vascular, for Promoting Embolization
NAJAgents, embolic, for treatment of uterine fibroids
NOYAgents, embolic, for treatment of benign prostatic hyperplasia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2
NAJAgents, Embolic, For Treatment Of Uterine FibroidsCardiovascular2
NOYAgents, Embolic, For Treatment Of Benign Prostatic HyperplasiaGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506011376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506011376001915060113761915060113760191506011376

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.

Sterilization Methods#

Method table
Method

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
08714729860624Expel™ Drainage Catheter with Twist-Loc™ HubH749393110825K12015-09-24
08714729860631Expel™ Drainage Catheter with Twist-Loc™ HubH749393111025K12015-09-24
00802526060915FINELINE® II Sterox44572014-09-24
00802526061936FINELINE® II Sterox44792014-09-24
00802526061974FINELINE® II Sterox44802014-09-24
00802526087752FINELINE® II Sterox44562014-09-24
00802526264993FINELINE® II EZ Sterox44702014-09-24
00802526265006FINELINE® II EZ Sterox44712014-09-24
00802526265143FINELINE® II EZ Sterox44692014-09-24
08714729936176ACUITY™706070602016-09-24
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24

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