Monarch™ Thermoplastic Frame
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Monarch™ Thermoplastic Frame FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- For use with Monarch™ Overhead Arm Positioner FDA UDI
- Model / Reference
- OAP120 EUDAMEDFDA UDIBreast Positioning Devices EUDAMED
- Description
- For use with Monarch™ Overhead Arm Positioner FDA UDI
Identifiers
- Catalog Number
- OAP120 FDA UDI
- Primary DI / UDI-DI
- 00841439111383 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0010R019Y EUDAMED
- 510(k) Number
- K974703 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological arm/leg positioner 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Radiological arm/leg positioner
Monarch™ Thermoplastic Frame by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K974703 also covers:
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Breastboard — Medtec LLC
- C-Qual M™ — Medtec LLC
- C-Qual™ — Medtec LLC
- C-Qual™ — Medtec LLC
- C-Qual™ — Medtec LLC
- Hip Stop — Medtec LLC
- Hip Stop — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- New Horizon Prone Breastboard — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 1d1c838c-5632-4077-9dd3-6e25709e21d2 36 fields · synced Jul 13, 2026
- EUDAMED a6385037-02cf-40ad-be46-877eded85916 61 fields · synced Jul 13, 2026