FDA.reportPublic FDA data

LC Bead LUMI 100 - 300

Primary DI
05060116921168
Brand
LC Bead LUMI 100 - 300
Company
BIOCOMPATIBLES UK LTD
Model
RO2L103
Device description
Embolic spheres
Published
2016-08-11
Public version status
Update
Distribution status
Not 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
05060116921168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060116921168050601169211685060116921168

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
+441252732732medical.services@btgplc.com

Regulatory Flags#

DUNS number
222870839
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060116921205LC Bead LUMI 300 - 500RO2L3052016-08-11
05060116920635TheraSphere Administration SetOTT-SPE-FP-0012018-11-01
05060116921328Varithena® Administration PackFP000242020-09-30
05060116921373TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921380TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921397TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921403TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921410TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921427TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921434TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921441TheraSphere Y90 Glass Microspheres 6.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921458TheraSphere Y90 Glass Microspheres 7.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921465TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921472TheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921489TheraSphere Y90 Glass Microspheres 8.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921496TheraSphere Y90 Glass Microspheres 9.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921502TheraSphere Y90 Glass Microspheres 9.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921519TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921526TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921533TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19

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