AccessGUDID - DEVICE: TheraSphere Y90 Glass Microspheres 15.5 GBq (US Commercial) (05060116921625)

GUDID

Device Identifier (DI) Information

Brand Name: TheraSphere Y90 Glass Microspheres 15.5 GBq (US Commercial)
Version or Model: OTT-SPE-FP-700 (990700.SPE)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOCOMPATIBLES UK LTD

Primary DI Number: 05060116921625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 222870839 *Terms of Use
Previous DI: 05060116920543

Device Description: TheraSphere Yttrium-90 Glass Microspheres 15.5 GBq Dose (US Commercial)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 533ee7f0-e3a7-4d44-a311-15e342c63be5
Public Version Date: September 29, 2021
Public Version Number: 2
DI Record Publish Date: June 19, 2020