Identity
- Trade Name
- MasterPeace EUDAMEDFDA UDI
- Generic Name
- Patient radiation shielding pad/drape, reusable FDA UDI
- Device Name
- Patch for Patient Torso to reduce scatter radiation, with Collar, Large EUDAMEDPatch for Patient to reduce scatter radiation, L-shape, Versatile Position. FDA UDI
- Model / Reference
- PS-3450 EUDAMEDPS3450 FDA UDI
- Description
- Patch for Patient to reduce scatter radiation, L-shape, Versatile Position. FDA UDI
Identifiers
- Catalog Number
- PS3450 FDA UDI
- Primary DI / UDI-DI
- 07350121950924 EUDAMEDFDA UDI
- Basic UDI-DI
- 735012195MasterpeaceDZ EUDAMED
- Direct Marketing DI
- 07350121950924 EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Patient radiation shielding pad/drape, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- Sweden 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 60 Centimeter FDA UDILength — 60 Centimeter FDA UDI
MasterPeace by Texray AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 735012195MasterpeaceDZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Texray AB
- EUDAMED SRN
- SE-MF-000042840
Sources (2)
- EUDAMED 7d3bc8b8-afe6-4e8c-90fc-4d57a22dc418 61 fields · synced May 30, 2026
- FDA UDI 8752cabb-96ae-4431-b7f1-2de235e726d4 35 fields · synced May 30, 2026