FDA.reportPublic FDA data

Gel-Bead™ Embolization Spheres

Primary DI
M20638210
Brand
Gel-Bead™ Embolization Spheres
Company
Vascular Solutions, Inc.
Model
3821
Published
2018-02-21
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

Contact Domains#

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
M20638210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, animal-derivedA sterile, 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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-240-6001customerservice@vasc.com

Regulatory Flags#

DUNS number
008999906
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M20679600VSI StraitSet™ micro-introducer kit79602018-08-09
M20679610VSI StraitSet™ micro-introducer kit79612018-08-09
M20679620VSI StraitSet™ micro-introducer kit79602018-08-09
M20679640VSI StraitSet™ micro-introducer kit79602018-08-09
M20679650VSI StraitSet™ micro-introducer kit79612018-08-09
M20679710VSI StraitSet™ micro-introducer kit79612018-08-09
M206780500SmartNeedle® vascular access system780502016-09-06
M206780600SmartNeedle® vascular access system780602016-09-06
M206780300SmartNeedle® vascular access system780302016-09-05
M206780400SmartNeedle® vascular access system780402016-09-06
M206720000SmartNeedle® monitor720002016-09-23
M20631010Thrombix® Hemostasis Patch topical hemostat31012016-09-15
M20630100D-Stat® 2 Dry topical hemostat30102016-09-15
M20681500Teirstein Edge™ device organizer81502016-09-05
M20681510Angio Assist™ docking station81512016-09-05
M20673710Axis™ guidewire73712016-09-05
M20673720Axis™ guidewire73722016-09-05
M20674720VSI Tru-Torque™ guidewire74722016-09-05
M20674730VSI Tru-Torque™ guidewire74732016-09-05
M20674790Amplatz SST™ guidewire74792016-09-05

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Primary DI, Brand, Company table
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00840303712107Prestige Coil SystemBALT USA LLCKRD2026-07-14
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
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06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053485Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053492Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053508Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
07613327635096InZone ISTStryker CorporationKRD2026-07-08
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