FDA UDI
In Commercial Distribution
🇺🇸 United States
VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source
DI: 00816389028869
·
Model: AL09400000
·
Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source
- Primary DI
- 00816389028869
- Version / Model
- AL09400000
- Catalog Number
- AL09400000
- Company Name
- Varian Medical Systems Deutschland GmbH
- Labeler DUNS
- 332474605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-09
- Public Version
- 1
- Public Version Date
- 2022-01-17
- Public Version Status
- New
- Public Device Record Key
- a3a5da28-baa6-4d8a-bd24-5f639f62ac2e
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAQ | System, applicator, radionuclide, remote-controlled | Radiology | 892.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38302 | Remote-afterloading brachytherapy source | A device that is a naturally-occurring, accelerator or reactor produced-radioactive isotope used as a source of radiation in high or low dose rate remote afterloading brachytherapy systems designed to deliver curative or palliative radiotherapy treatments. Sources used in remote afterloading radiotherapy systems may come in a variety of strengths and physical forms, e.g., single encapsulated source (sealed source), ribbons, plated, foil or embedded sources or contained radioactive liquids or gels. It is typically housed in a shielded safe within the remote afterloading system and delivered through guide tubes or catheters to the treatment site by various remote-controlled mechanisms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816389028869 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122236 | 000 |