Identity
- Trade Name
- MasterPeace EUDAMEDFDA UDI
- Generic Name
- Radiation shielding table drape FDA UDI
- Device Name
- Patch for Patient Torso to reduce scatter radiation, with Collar, Large EUDAMEDTable-Mounted Radiation Source Leakage Shield, Sliding Extention, Position Right/Left. FDA UDI
- Model / Reference
- TS-5050 EUDAMEDTS5050 FDA UDI
- Description
- Table-Mounted Radiation Source Leakage Shield, Sliding Extention, Position Right/Left. FDA UDI
Identifiers
- Catalog Number
- TS5050 FDA UDI
- Primary DI / UDI-DI
- 07350121950986 EUDAMEDFDA UDI
- Basic UDI-DI
- 735012195MasterpeaceDZ EUDAMED
- Direct Marketing DI
- 07350121950986 EUDAMED
- FDA Product Code
- IWX FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Radiation shielding table drape 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 — 50 Centimeter FDA UDILength — 50 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 6a160ddc-d0bf-4572-abb4-db022740dcda 61 fields · synced May 30, 2026
- FDA UDI 9108bfbc-e6dc-4607-b4a2-c504ffbbd35c 35 fields · synced May 30, 2026