Nasion Cushion
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Nasion Cushion FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- For use with trUpoint ARCH™ FDA UDI
- Model / Reference
- MTHF016 EUDAMEDFDA UDIStereotactic Radiosurgery and Stereotactic Radiotherapy Devices EUDAMED
- Description
- For use with trUpoint ARCH™ FDA UDI
Identifiers
- Catalog Number
- MTHF016 FDA UDI
- Primary DI / UDI-DI
- 10841439104221 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0019R01BX EUDAMED
- 510(k) Number
- K132908 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Stereotactic radiosurgical/radiotherapy arch head frame
Nasion Cushion by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic radiosurgical/radiotherapy arch head frame.
- Fraxion — 3C-Medical Intelligence GmbH · Class II
- Arch Kit, PositionPro — Aktina Corp. · Class II
- ShoulderAssist, PositionPro — Aktina Corp. · Class II
- PinPoint Arch Support, Extended — Aktina Corp. · Class II
- PinPoint Radiosurgery Immobilization System, Elekta Compatible — Aktina Corp. · Class II
- BodyFIX — 3C-Medical Intelligence GmbH · Class II
- Carbon Fiber Board, Short — Aktina Corp. · Class II
- PinPoint Mouthpiece Assembly, Medium — Aktina Corp. · Class II
Cleared under the same submission
K132908 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI 4038030f-caef-4fa3-bab5-1fba0b5d000e 36 fields · synced Jun 18, 2026
- EUDAMED 5507451e-5545-4758-bf19-bdc4da549bbb 61 fields · synced Jun 18, 2026