← Back to catalogue
Access 360™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4544KV-12Model Breast and Pelvis
by Qfix
Identity
- Trade Name
- Access 360™ FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Device Name
- kVue Access 360 G2 Left Insert FDA UDI
- Model / Reference
- RT-4544KV-12 EUDAMEDFDA UDIBreast and Pelvis EUDAMED
- Description
- kVue Access 360 G2 Left Insert FDA UDI
Identifiers
- Catalog Number
- RT-4544KV-12 FDA UDI
- Primary DI / UDI-DI
- 10841962108802 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621BREASTPELVISTG EUDAMED
- FDA Product Code
- JAI 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
- 892.5770 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological breast positioner, non-wearable
Access 360™ by Qfix — 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
- C-Qual™ — Medtec LLC · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Positioning Cushion — Medtec LLC · Class II
- SenoView Prone Breast Board — Aktina Corp. · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Monarch™ Overhead Arm Positioner — Medtec LLC · Class II
- C-Qual™ — Medtec LLC · Class II
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
- Qfix
Sources (2)
- FDA UDI 91d190b1-389a-440d-978e-b7ab01be81fa 35 fields · synced Jun 19, 2026
- EUDAMED d909129b-c1a6-48f5-b899-00254490a13c 61 fields · synced Jun 19, 2026