Mask DSPS®-PROSL, set/5
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Mask DSPS®-PROSL EUDAMEDFDA UDIMask DSPS®-PROSHL EUDAMEDMask DSPS®-PROSL, set/5 FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- DSPS-Prominent EUDAMEDDSPS Prominent Mask Set Supine, head and shoulder for long hair, set of 5 FDA UDIDSPS Prominent Mask Set Supine, head and shoulder for long hair FDA UDI
- Model / Reference
- 113980M EUDAMED113920M EUDAMEDDSPS-PROSL FDA UDIDSPS-PROSLPc FDA UDI
- Description
- DSPS Prominent Mask Set Supine, head and shoulder for long hair, set of 5 FDA UDIDSPS Prominent Mask Set Supine, head and shoulder for long hair FDA UDI
Identifiers
- Catalog Number
- 113980 FDA UDI113980M FDA UDI
- Primary DI / UDI-DI
- 08720168162281 EUDAMEDFDA UDI08720168162625 EUDAMED08720168162267 FDA UDI
- Basic UDI-DI
- 872016816113000GT EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Patient positioning thermoplastic mould material
Mask DSPS®-PROSL, set/5 by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Macromedics B.v.
Sources (4)
- FDA UDI 542aa52c-3569-45b1-ab99-2000dbdce843 34 fields · synced Jul 11, 2026
- FDA UDI 9944ca07-17d4-414d-82f1-ace7e8c967ec 34 fields · synced May 29, 2026
- EUDAMED c691771f-54dc-4f3f-ae11-7cac2a2f799e 61 fields · synced Jul 10, 2026
- EUDAMED 67cc42da-ad22-42b9-bd41-bda98ab1bf8e 61 fields · synced Jul 11, 2026