Identity
- Trade Name
- Headrest FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Device Name
- Reusable non-sterile (16 x 15.2 x 5.8cm) gel headrest FDA UDI
- Model / Reference
- MT250SUB5 FDA UDI
- Description
- Reusable non-sterile (16 x 15.2 x 5.8cm) gel headrest FDA UDI
Identifiers
- Catalog Number
- MT250SUB5 FDA UDI
- Primary DI / UDI-DI
- 00841439102527 FDA UDI
- 510(k) Number
- K935411 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological breast positioner, non-wearable 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
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 6 Inch FDA UDILength — 6.27 Inch FDA UDI
Headrest by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K935411 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 |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI 95dd680e-09ff-492a-a135-0f9a55dd1380 38 fields · synced May 30, 2026