Identity
- Trade Name
- LANDAUER FDA UDI
- Generic Name
- MOSFET radiation therapy dosimetry system FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- microSTAR® ii Dosimetry System FDA UDI
- 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). FDA UDI
Identifiers
- Catalog Number
- 18000-000 FDA UDI
- Primary DI / UDI-DI
- 00860003399903 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- MOSFET radiation therapy dosimetry system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: MOSFET radiation therapy dosimetry system
Landauer by Landauer — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Landauer
Sources (1)
- FDA UDI 64e33ce9-e878-4281-91d3-90c0db299731 34 fields · synced May 31, 2026