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ProForm™ MR Overlay
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref PRO320
by Medtec LLC
Identity
- Trade Name
- ProForm™ MR Overlay FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Couchtop EUDAMEDProForm™ MR Overlay FDA UDI
- Model / Reference
- PRO320 EUDAMEDFDA UDI
- Description
- ProForm™ MR Overlay FDA UDI
Identifiers
- Catalog Number
- PRO320 FDA UDI
- Primary DI / UDI-DI
- 00841439113158 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0007R01B6 EUDAMED
- 510(k) Number
- K180021 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
ProForm™ MR Overlay by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K180021 also covers:
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- Interface Plate — Medtec LLC
- Interface for Varian — Medtec LLC
- Patient Hand Grip — Medtec LLC
- Patient Handle, Left — Medtec LLC
- Pediatric Cushion Guide — Medtec LLC
- Pediatric Registration Film — Medtec LLC
- Posifix® Extension — Medtec LLC
- Positioning Cushion — Medtec LLC
- ProForm™ Head and Neck Extension — Medtec LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 f24069d3-e4b9-4f81-bb7b-edc0485e160a 36 fields · synced Oct 6, 2026
- EUDAMED 1ee4f99b-6901-4895-9ec3-25d071f89753 61 fields · synced Jul 14, 2026