FDA UDI
In Commercial Distribution
🇺🇸 United States
TheraSphere Administration Set
DI: 05060116920253
·
Model: 990226.SPE
·
BIOCOMPATIBLES UK LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TheraSphere Administration Set
- Primary DI
- 05060116920253
- Version / Model
- 990226.SPE
- Company Name
- BIOCOMPATIBLES UK LTD
- Labeler DUNS
- 222870839
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2021-09-29
- Public Version Status
- Update
- Public Device Record Key
- 0a306c99-a555-4748-af3b-ac772004df36
Device Description
Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAW | Microspheres Radionuclide | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060116920253 | GS1 | ||||
| Package | 05060116920260 | GS1 | Packaging Box | 5 | In Commercial Distribution | |
| Package | 05060116920277 | GS1 | Shipping Box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-866-363-3330
- [email protected]