Identity
- Trade Name
- DUROLANE FDA UDI
- Generic Name
- Synovial fluid supplementation medium FDA UDI
- Device Name
- DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate- buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen. FDA UDI
- Model / Reference
- 1082020 FDA UDI
- Description
- DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate- buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen. FDA UDI
Identifiers
- Catalog Number
- 1082020 FDA UDI
- Primary DI / UDI-DI
- 00816986020808 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 Bioventus Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Synovial fluid supplementation medium.
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- ORTHOVISC — SAIMA GLOBAL FARMA S.L. · 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
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
- Bioventus Llc
Sources (1)
- FDA UDI 0568a2f4-3e60-4c2f-9f28-d40c3695327d 37 fields · synced May 30, 2026