Identity
- Trade Name
- KLARITY MEDICAL FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Prone Breast System, complete set with Carbon Fiber Baseplate, 2 contralateral cushions, 2 ProneHead Supports and baseplate, Lateral Head Support, 2 Wedge AccuCushions, and Upper Vacuum Bag. FDA UDI
- Model / Reference
- R6400-CF FDA UDI
- Description
- Prone Breast System, complete set with Carbon Fiber Baseplate, 2 contralateral cushions, 2 ProneHead Supports and baseplate, Lateral Head Support, 2 Wedge AccuCushions, and Upper Vacuum Bag. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817355023079 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
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient positioning thermoplastic mould materialIndexed-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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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 5cc30fd8-a519-41a3-93dd-14d0224d0b05 33 fields · synced Jun 9, 2026