FDA UDI
In Commercial Distribution
🇺🇸 United States
The AIO Solution
DI: 05420028706985
·
Model: 32291
·
Orfit Industries NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- The AIO Solution
- Primary DI
- 05420028706985
- Version / Model
- 32291
- Company Name
- Orfit Industries NV
- Labeler DUNS
- 283679900
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-15
- Public Version
- 1
- Public Version Date
- 2026-04-23
- Public Version Status
- New
- Public Device Record Key
- b42a5919-4d4b-4841-b8a1-45d42c5b899e
Device Description
AIO Head and Neck
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 61129 | Patient positioner base plate | A device in the form of a non-mirrored flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices (not included) can be attached [e.g., arch frame, thermoplastic mask, headrest, head positioner]. It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05420028706985 | GS1 |
Customer Contacts
- Phone
- +1(888)673-4903
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991319 | 000 |