FDA.report

LC Bead LUMI 40 - 90

Primary DI
05060116921229
Brand
LC Bead LUMI 40 - 90
Company
BIOCOMPATIBLES UK LTD
Model
RO2L000
Device description
Embolic spheres
Published
2017-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications

CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060116921229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060116921229050601169212295060116921229

GMDN Terms

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

Contacts

PhoneEmail
+441252732732medical.services@btgplc.com

Regulatory Flags

DUNS number
222870839
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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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
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05060116921533TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921540TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921557TheraSphere Y90 Glass Microspheres 12.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19

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