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

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
05060116920635TheraSphere Administration SetOTT-SPE-FP-0012018-11-01
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150044177Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044184Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044191Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044207Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724255Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724262Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724279Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724286Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16