Identity
- Trade Name
- trUpoint ARCH™ FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- Stereotactic head frame FDA UDI
- Model / Reference
- MTHF01 FDA UDI
- Description
- Stereotactic head frame FDA UDI
Identifiers
- Catalog Number
- MTHF01 FDA UDI
- Primary DI / UDI-DI
- 00841439104217 FDA UDI
- 510(k) Number
- K132908 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Stereotactic radiosurgical/radiotherapy arch head frame 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Stereotactic radiosurgical/radiotherapy arch head frame
trUpoint ARCH™ by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic radiosurgical/radiotherapy arch head frame.
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- PinPoint Mouthpiece Assembly, Medium — Aktina Corp. · Class II
Cleared under the same submission
K132908 also covers:
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
- Medtec LLC
Sources (1)
- FDA UDI 04dc130a-9f66-4568-a415-ae19b34849dd 36 fields · synced May 30, 2026