Pro Handle
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Pro Handle FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Device Name
- For use with Pro Wing Board™ or Monarch™ FDA UDI
- Model / Reference
- OAP221 EUDAMEDFDA UDIBreast Positioning Devices EUDAMED
- Description
- For use with Pro Wing Board™ or Monarch™ FDA UDI
Identifiers
- Catalog Number
- OAP221 FDA UDI
- Primary DI / UDI-DI
- 00841439114131 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0010R019Y EUDAMED
- 510(k) Number
- K211001 FDA UDI
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological breast positioner, non-wearable 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
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 breast positioner, non-wearable
Pro Handle by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological breast positioner, non-wearable.
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- SenoView Prone Breast Board — Aktina Corp. · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Quest™ — Qfix · Class II
- Access™ Supine — Qfix · Class II
- Breast Riser CX — QUALITY ELECTRODYNAMICS LLC · Class I
- ArmCradle4 — Aktina Corp. · Class II
Cleared under the same submission
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 e2346c83-2d77-4342-bb24-c9c38a7a61bc 36 fields · synced Jun 19, 2026
- EUDAMED d6aaabcc-b38e-4283-b2ba-cf2f8269f0bf 61 fields · synced Jun 19, 2026