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Customizable Head Support
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CHS01Model Head, Neck, and Shoulder Devices
by Medtec LLC
Identity
- Trade Name
- Customizable Head Support FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- Head support for Posifix® systems FDA UDI
- Model / Reference
- CHS01 EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- Head support for Posifix® systems FDA UDI
Identifiers
- Catalog Number
- CHS01 FDA UDI
- Primary DI / UDI-DI
- 00841439102350 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological headrest 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
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
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
- Width — 7.2 Inch FDA UDILength — 10.5 Inch FDA UDI
Category: Radiological headrest
Customizable Head Support by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological headrest.
- Neck & Brachial Plexus SatPad™ Set — Sat Pad Inc. · Class II
- Nurofit Premiere™ — Qfix · Class I
- Neuro Head Holder — Qfix · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- DSA-3Q Head Holder — Qfix · Class I
- DSA-2T Head Holder — Qfix · Class I
- pearltec — Pearl Technology AG · Class I
Cleared under the same submission
K080072 also covers:
- Elekta Unity Lok-Bar™ — Medtec LLC
- Elekta Unity QA Lok-Bar™ — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- Slide Guide 3-Pin Lok-Bar™ — Medtec LLC
- Thermoplastic Frame — Medtec LLC
- Type-S™ Thermoplastic — Medtec LLC
- Type-S™ Thermoplastic — Medtec LLC
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 II | Unknown |
| 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 (2)
- FDA UDI 1ee61faa-d484-4c33-adf0-c3c2b06c556c 37 fields · synced Aug 2, 2026
- EUDAMED 2dc4a68a-54cb-4327-ac5c-461fc245af6a 61 fields · synced Aug 2, 2026