Identity
- Trade Name
- Mask SSPS™-FVR EUDAMEDFDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- DSPS & SSPS cradle and mask EUDAMEDSSPS Mask head only, Type-VRT, open face FDA UDI
- Model / Reference
- 115810M EUDAMEDSSPS-FVRPc FDA UDI
- Description
- SSPS Mask head only, Type-VRT, open face FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719425705743 EUDAMEDFDA UDI
- Basic UDI-DI
- 872016816112100GR EUDAMED
- 510(k) Number
- K142420 FDA UDI
- 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
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Patient positioning thermoplastic mould material
Mask SSPS™-FVR by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K142420 also covers:
- Adaptor MaxSupport™ TO — MACROMEDICS B.V.
- Adaptor MaxSupport™ TS — MACROMEDICS B.V.
- Block high CF ExaFix™ — MACROMEDICS B.V.
- Block low CF ExaFix™ — MACROMEDICS B.V.
- BreastBoardLX™ — MACROMEDICS B.V.
- CouchStrip CSMF — MACROMEDICS B.V.
- CouchStrip CSMFGF — MACROMEDICS B.V.
- CouchStrip CSNF — MACROMEDICS B.V.
- CouchStrip CSNFCF — MACROMEDICS B.V.
- CouchStrip CSWF — MACROMEDICS B.V.
- DSCP™ KS indexstrip — MACROMEDICS B.V.
- DSPS® Cradle-MEXF H MR — MACROMEDICS B.V.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (2)
- FDA UDI 0b347ab3-f548-4337-899d-eabcf0439784 34 fields · synced Jul 17, 2026
- EUDAMED 6febe549-e42d-4b65-ac17-58cf0b159698 61 fields · synced Jul 17, 2026