FDA.reportPublic FDA data

LC Bead 300-500

Primary DI
05060116920192
Brand
LC Bead 300-500
Company
BOSTON SCIENTIFIC CORPORATION
Model
VE420GS
Device description
Embolic spheres
Published
2015-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDevice, Neurovascular Embolization
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060116920192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060116920192050601169201925060116920192

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401252732732medical.services@btgplc.com

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
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

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00763000495640Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488734Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00847536032828AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033085AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033085AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033122AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033122AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033146AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033146AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033221AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033221AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033382AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033382AxiumTMMicro Therapeutics, Inc.KRD2019-06-29