Identity
- Trade Name
- KLARITY MEDICAL FDA UDI
- Generic Name
- Patient positioning foam mould kit FDA UDI
- Device Name
- Item ID R550-LB2 Vendor Name/Code Description Klarity Cushion™ custom mold for Ear Use 10cm x 10cm FDA UDI
- Model / Reference
- R550-LB2 FDA UDI
- Description
- Item ID R550-LB2 Vendor Name/Code Description Klarity Cushion™ custom mold for Ear Use 10cm x 10cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817355028616 FDA UDI
- 510(k) Number
- K132124 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Patient positioning foam mould kit 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Patient positioning foam mould kit
Klarity Medical by Klarity Medical Products, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning foam mould kit.
- AccuForm™ Cushion — Medtec LLC · Class II
- Pediatric Cushion Guide — Medtec LLC · Class II
- Pediatric Registration Film — Medtec LLC · Class II
- AccuForm™ Cushion — Medtec LLC · Class II
- AccuForm™ Cushion — Medtec LLC · Class II
- RediFoam™ — Medtec LLC · Class II
- RediFoam™ — Medtec LLC · Class II
- TOTIM Patient Cushion Immobilization System — Essebi Medical Srl · Class II
Cleared under the same submission
K132124 also covers:
- TrueForm — IZI MEDICAL PRODUCTS LLC
- TrueForm — IZI MEDICAL PRODUCTS LLC
- Vacuum Bag — IZI MEDICAL PRODUCTS LLC
- Vacuum Bag — IZI MEDICAL PRODUCTS LLC
- Vacuum Bag — IZI MEDICAL PRODUCTS LLC
- Vacuum Bag — IZI MEDICAL PRODUCTS LLC
- Vacuum Bag — IZI MEDICAL PRODUCTS LLC
- Vacuum Bag — IZI MEDICAL PRODUCTS LLC
- KLARITY MEDICAL — Klarity Medical Products, LLC
- KLARITY MEDICAL — Klarity Medical Products, LLC
- KLARITY MEDICAL — Klarity Medical Products, LLC
- KLARITY MEDICAL — Klarity Medical Products, LLC
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
- Klarity Medical Products, LLC
Sources (1)
- FDA UDI cd0ddb72-b62e-424f-8e06-df34874ee72f 34 fields · synced Jun 9, 2026