Identity
- Trade Name
- AQUALGEL FDA UDI
- Generic Name
- Leg/knee cushion FDA UDI
- Device Name
- AQUAGEL Leg Protector is 3-dimensional and provides ultimate pressure relief for the heel as it stabilizes the lower leg and protects the knee from hyperextension. FDA UDI
- Model / Reference
- BF478 FDA UDI
- Description
- AQUAGEL Leg Protector is 3-dimensional and provides ultimate pressure relief for the heel as it stabilizes the lower leg and protects the knee from hyperextension. FDA UDI
Identifiers
- Catalog Number
- BF478 FDA UDI
- Primary DI / UDI-DI
- 00724995219963 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Leg/knee cushion FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Leg/knee cushion
Aqualgel by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Leg/knee cushion.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- BoneFoam — Bone Foam, Inc. · Class I
- BoneFoam — Bone Foam, Inc. · Class I
- BoneFoam — Bone Foam, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- BoneFoam — Bone Foam, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Steris Corporation
Sources (1)
- FDA UDI d11d08bf-a663-432d-b6b6-74fbb20d5e00 36 fields · synced Jun 8, 2026