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Wedge
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 107102MRModel Head, Neck, and Shoulder Devices
by Medtec LLC
Identity
- Trade Name
- Wedge FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- 5 degree wedge, MR FDA UDI
- Model / Reference
- 107102MR EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- 5 degree wedge, MR FDA UDI
Identifiers
- Catalog Number
- 107102MR FDA UDI
- Primary DI / UDI-DI
- 00841439114612 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- 510(k) Number
- K180021 FDA UDI
- FDA Product Code
- IYE FDA UDILNH 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 UDI892.1000 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
Category: Radiological headrest
Wedge by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological headrest.
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- Neuro Head Holder — Qfix · Class I
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- DSA-2T Head Holder — Qfix · Class I
- pearltec — Pearl Technology AG · Class I
Cleared under the same submission
K180021 also covers:
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- Patient Hand Grip — Medtec LLC
- Pediatric Cushion Guide — Medtec LLC
- Pediatric Registration Film — Medtec LLC
- Positioning Cushion — Medtec LLC
- ProForm™ Pediatric Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ 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 |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI fea6767d-ee66-47ef-8ff6-48e439309ba4 36 fields · synced Jul 10, 2026
- EUDAMED 2a6ccac2-06ca-4dcb-bfdc-5d884ba920c7 61 fields · synced Jul 10, 2026