FDA UDI
In Commercial Distribution
🇺🇸 United States
LANDAUER
DI: 00860003399903
·
Model: microSTAR® ii Dosimetry System
·
LANDAUER, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LANDAUER
- Primary DI
- 00860003399903
- Version / Model
- microSTAR® ii Dosimetry System
- Catalog Number
- 18000-000
- Company Name
- LANDAUER, INC.
- Labeler DUNS
- 189807159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-12
- Public Version
- 1
- Public Version Date
- 2020-02-20
- Public Version Status
- New
- Public Device Record Key
- 64e33ce9-e878-4281-91d3-90c0db299731
Device Description
The LANDAUER microSTAR®ii dosimetry system includes a compact, lightweight and portable dosimeter reader that relies on Optically Stimulated Luminescence (OSL) technology for secondary verification of radiation dose for patient therapy Quality Assurance (QA).
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
- No
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60320 | MOSFET radiation therapy dosimetry system | An assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. It typically consists of several wire-connected MOSFET dosimeters, a portable battery-powered dosimeter reader, and application software; it may include wireless data exchanging technology. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003399903 | GS1 |