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Prone Head Holder
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref MT202Model Head, Neck, and Shoulder Devices
by Medtec LLC
Identity
- Trade Name
- Prone Head Holder FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- with gel pads (2) FDA UDI
- Model / Reference
- MT202 EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- with gel pads (2) FDA UDI
Identifiers
- Catalog Number
- MT202 FDA UDI
- Primary DI / UDI-DI
- 00841439102466 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- FDA Product Code
- IWY FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1920 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Inch FDA UDILength — 12 Inch FDA UDI
Category: Patient positioner base plate
Prone Head Holder by Medtec LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI e42c4c04-82eb-46be-8d4e-fa349cacc35a 37 fields · synced Jun 19, 2026
- EUDAMED a68396d1-fac9-4145-bf76-342c63f99bcf 61 fields · synced Jun 19, 2026