Identity
- Trade Name
- L Head and Arm Cushions FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Model / Reference
- CO-03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B525CO030 FDA UDI
- FDA Product Code
- KXH FDA UDI
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1830 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological whole-body positioner
L Head and Arm Cushions by Octostop Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological whole-body positioner.
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- iCAST Head US Maxi 2mm — IT-V Medizintechnik GmbH · Class II
- iCAST H&S Micro 2mm — IT-V Medizintechnik GmbH · Class II
- MCT Wedge Indexing Bar for Elekta — IT-V Medizintechnik GmbH · Class II
- Orfit Industries — Orfit Industries NV · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Octostop Inc
Sources (1)
- FDA UDI 4212e0dd-914f-44e9-a372-62f99a74f85e 32 fields · synced Jun 6, 2026