Identity
- Trade Name
- Mask UMCN FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- DSPS Mask Prone Head FDA UDI
- Model / Reference
- DSPS-FOPPc FDA UDI
- Description
- DSPS Mask Prone Head FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719425707747 FDA UDI
- 510(k) Number
- K142420 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Patient positioning thermoplastic mould material
Mask UMCN by Macromedics B.v. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient positioning thermoplastic mould material.
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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 (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
- Macromedics B.v.
Sources (1)
- FDA UDI 427c4fc1-dafc-4f1a-9481-96aa15442855 34 fields · synced Jun 8, 2026