DEVICE: TheraSphere Y90 Glass Microspheres 15 GBq (05060116920321)

Device Identifier (DI) Information

TheraSphere Y90 Glass Microspheres 15 GBq
990700.SPE
In Commercial Distribution

BIOCOMPATIBLES UK LTD
05060116920321
GS1

1
222870839 *Terms of Use
TheraSphere Yttrium-90 Glass Microspheres 15 GBq Dose
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
NAW Microspheres Radionuclide
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a5977f2e-dae5-43f8-ad1c-5d3fe506d7d1
March 29, 2018
2
September 24, 2014
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-866-363-3330
TheraSphereCustomerSupport@btgplc.com
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