Identity
- Trade Name
- Orfit Industries FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- AIO Base Plate CFL FDA UDI
- Model / Reference
- 32301 FDA UDI
- Description
- AIO Base Plate CFL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05420028740743 FDA UDI
- 510(k) Number
- K191158 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological whole-body positioner 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Radiological whole-body positioner
Orfit Industries by Orfit Industries NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiological whole-body positioner.
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- iCAST Chin Double Micro 4mm — IT-V Medizintechnik GmbH · Class II
- BellySTEP Insert A - Medium — IT-V Medizintechnik GmbH · Class II
Cleared under the same submission
K191158 also covers:
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orfit Industries NV
Sources (1)
- FDA UDI 5be61154-8767-4fe4-b4b3-28218028ac33 35 fields · synced May 29, 2026