Identity
- Trade Name
- DUROLANE FDA UDI
- Generic Name
- Synovial fluid supplementation medium FDA UDI
- Device Name
- DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. FDA UDI
- Model / Reference
- 1082020 FDA UDI
- Description
- DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437027710001 FDA UDI
- PMA Number
- P170007 FDA UDI
- FDA Product Code
- MOZ FDA UDI
- GMDN Term
- Synovial fluid supplementation medium FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Synovial fluid supplementation medium
Durolane by Saima Global Farma S.l. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synovial fluid supplementation medium.
- Euflexxa — ACRE PHARMA LIMITED · Class III
- Gel-One® Cross-linked Hyaluronate — Seikagaku Corp. · Class III
- Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack — Fidia Farmaceutici · Class III
- Supartz — PAVAN TRADING LTD · Class III
- Supartz — Arcera GmbH · Class III
- VISCO-3 sodium hyaluronate — Seikagaku Corp. · Class III
- Synvisc One (Synvisc Three) — PAVAN TRADING LTD · Class III
- Euflexxa — PAVAN TRADING LTD · Class III
Cleared under the same submission
P170007 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Saima Global Farma S.l.
Sources (1)
- FDA UDI f8e3daab-8ab4-4c9d-9c2a-f351fbe96b46 35 fields · synced May 29, 2026