Identity
- Trade Name
- Klarity Medical FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- Vacuum Bag for Head & Shoulder Support 67x62cm 9 liter fill FDA UDI
- Model / Reference
- R7202-09 FDA UDI
- Description
- Vacuum Bag for Head & Shoulder Support 67x62cm 9 liter fill FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817355021051 FDA UDI
- 510(k) Number
- K132124 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Vacuum-mould 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: Vacuum-mould patient positioning system
Klarity Medical by Klarity Medical Products, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vacuum-mould patient positioning system.
- Vac-Lok™ Cushion — Medtec LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- VacuumCushion Pos.Strip — MACROMEDICS B.V. · Class II
- Helping Hands ™ — Medtec LLC · Class II
- VacQfix™ — Qfix · Class II
- VacQfix™ — Qfix · Class II
- Vac-Lok™ Cushion — Medtec LLC · 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 5aa11fca-49bc-40f6-a0a7-fb39acc6f0a2 35 fields · synced Jun 9, 2026