Identity
- Trade Name
- KLARITY MEDICAL FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Silverman (BIONIX) B Head & Neck Support (Acrylic) FDA UDI
- Model / Reference
- R507-BB FDA UDI
- Description
- Silverman (BIONIX) B Head & Neck Support (Acrylic) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817355027268 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
No
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 89e722c5-c256-4701-9a9d-646d3e8749a1 34 fields · synced Jun 9, 2026