Identity
- Trade Name
- KLARITY MEDICAL FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Klarity® UNO™ Prone Belly/Pelvic Cushion Set Includes: Upper Prone Cushion with Removable Port Cushions Tilting Prone Head Support Right and Left Upper Hand Grips Lower Prone Cushion with Groin Lock and Removable Pelvic Hole Cushion Foot Rest Cushion Upper Cushion Indexing Bar Lower Cushion Indexing Ba FDA UDI
- Model / Reference
- R616-AE5 FDA UDI
- Description
- Klarity® UNO™ Prone Belly/Pelvic Cushion Set Includes: Upper Prone Cushion with Removable Port Cushions Tilting Prone Head Support Right and Left Upper Hand Grips Lower Prone Cushion with Groin Lock and Removable Pelvic Hole Cushion Foot Rest Cushion Upper Cushion Indexing Bar Lower Cushion Indexing Ba FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817355028647 FDA UDI
- 510(k) Number
- K112460 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Indexed-immobilization patient positioning system 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: Indexed-immobilization patient positioning system
Klarity Medical by Klarity Medical Products, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112460 also covers:
- KLARITY MEDICAL — Klarity 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
- KLARITY MEDICAL — Klarity 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
- 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 fb7fdab5-beaa-4a93-8941-77288e464991 34 fields · synced Jun 9, 2026