Identity
- Trade Name
- Individual Head Support FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- with pocket base FDA UDI
- Model / Reference
- MTIHS01 FDA UDI
- Description
- with pocket base FDA UDI
Identifiers
- Catalog Number
- MTIHS01 FDA UDI
- Primary DI / UDI-DI
- 00841439104385 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological headrest FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Length — 12.2 Inch FDA UDI
Individual Head Support by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K132908 also covers:
K982624 also covers:
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- Customizable Head Support — Medtec LLC
- Customizable Head Support — Medtec LLC
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 |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI 1cc68401-85c1-427e-b5d7-d27d690e2c03 39 fields · synced May 30, 2026