Identity
- Trade Name
- Raycell FDA UDI
- Generic Name
- In vitro ionizing-radiation blood irradiator FDA UDI
- Device Name
- Blood Irradiator FDA UDI
- Model / Reference
- Mk2 FDA UDI
- Description
- Blood Irradiator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540146000043 FDA UDI
- FDA Product Code
- MOT FDA UDI
- GMDN Term
- In vitro ionizing-radiation blood irradiator FDA UDI
Classification
- Device Class
- U 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
Yes
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: In vitro ionizing-radiation blood irradiator
Raycell by Best Theratronics Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as In vitro ionizing-radiation blood irradiator.
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 U | Pending data |
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Manufacturer
- Manufacturer
- Best Theratronics Limited
Sources (1)
- FDA UDI 3822c34f-7de8-4a7b-82db-54f8efe860bc 34 fields · synced Jun 8, 2026