Pediatric Cushion Guide
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Pediatric Cushion Guide FDA UDI
- Generic Name
- Patient positioning foam mould kit FDA UDI
- Device Name
- Pediatric Cushion Guide FDA UDI
- Model / Reference
- PRO450 EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- Pediatric Cushion Guide FDA UDI
Identifiers
- Catalog Number
- PRO450 FDA UDI
- Primary DI / UDI-DI
- 00841439114049 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- 510(k) Number
- K180021 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient positioning foam mould kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Patient positioning foam mould kit
Pediatric Cushion Guide by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning foam mould kit.
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
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Cleared under the same submission
K180021 also covers:
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- Patient Hand Grip — Medtec LLC
- Pediatric Registration Film — Medtec LLC
- Positioning Cushion — Medtec LLC
- ProForm™ Pediatric Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
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
- Medtec LLC
Sources (2)
- FDA UDI f56dc520-f8ff-4aea-816c-19b3814f14db 36 fields · synced Jul 29, 2026
- EUDAMED a43ef875-9d06-46a6-a584-b0e4e58d3b70 61 fields · synced Jun 14, 2026