FDA UDI
In Commercial Distribution
🇺🇸 United States
TheraSphere Administration Set
DI: 05060116920635
·
Model: OTT-SPE-FP-001
·
BIOCOMPATIBLES UK LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- TheraSphere Administration Set
- Primary DI
- 05060116920635
- Version / Model
- OTT-SPE-FP-001
- Company Name
- BIOCOMPATIBLES UK LTD
- Labeler DUNS
- 222870839
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-01
- Public Version
- 2
- Public Version Date
- 2021-09-29
- Public Version Status
- Update
- Public Device Record Key
- 7182fc2f-39f0-4238-9d0f-00e43cc6f4e9
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 |
|---|---|---|---|---|
| 61711 | Manual-afterloading brachytherapy system source delivery procedure kit | A collection of sterile devices intended to dispense/collect hydraulic fluid used to deliver the radiation source train of a manual-afterloading brachytherapy system source transfer device to/from the delivery catheter/applicator. It consists of disposable devices such as syringes, fluid collection bags, adaptors/connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060116920659 | GS1 | Shipping Box | 20 | In Commercial Distribution | |
| Package | 05060116920642 | GS1 | Packaging Box | 5 | In Commercial Distribution | |
| Primary | 05060116920635 | GS1 |
Customer Contacts
- Phone
- 1-866-363-3330
- [email protected]