DEVICE: TheraSphere Y90 Glass Microspheres 16.5 GBq (05060116920567)
Device Identifier (DI) Information
TheraSphere Y90 Glass Microspheres 16.5 GBq
990700.SPE
Not in Commercial Distribution
BIOCOMPATIBLES UK LTD
990700.SPE
Not in Commercial Distribution
BIOCOMPATIBLES UK LTD
TheraSphere Yttrium-90 Glass Microspheres 16.5 GBq Dose
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38303 | Manual brachytherapy source, permanent implant |
A 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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAW | Microspheres Radionuclide |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
80c150af-73bb-4ec8-b8a6-703b09c4fbe0
September 29, 2021
4
September 24, 2014
September 29, 2021
4
September 24, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-866-363-3330
TheraSphereCustomerSupport@btgplc.com
TheraSphereCustomerSupport@btgplc.com