FDA.report

TheraSphere Y90 Glass Microspheres 12.0 GBq

Primary DI
05060116920482
Brand
TheraSphere Y90 Glass Microspheres 12.0 GBq
Company
BIOCOMPATIBLES UK LTD
Model
990700.SPE
Device description
TheraSphere Yttrium-90 Glass Microspheres 12.0 GBq Dose
Published
2014-09-24
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
NAWMicrospheres Radionuclide

Product Code Classifications

CodeDeviceSpecialtyClass
NAWMicrospheres RadionuclideUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060116920482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060116920482050601169204825060116920482

GMDN Terms

TermDefinition
Manual brachytherapy source, permanent implantA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.

Sterilization Methods

Method

Contacts

PhoneEmail
1-866-363-3330TheraSphereCustomerSupport@btg
1-866-363-3330TheraSphereCustomerSupport@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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
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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00191506025496TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
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