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Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL FDA UDI
- Generic Name
- Synovial fluid supplementation medium FDA UDI
- Device Name
- Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. FDA UDI
- Model / Reference
- 89122-0724-20 FDA UDI
- Description
- Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. FDA UDI
Identifiers
- Catalog Number
- 89122-0724-20 FDA UDI
- Primary DI / UDI-DI
- M713891220724200 FDA UDI
- PMA Number
- P950027 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
Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL by Fidia Farmaceutici — 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
- 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
- Euflexxa — PAVAN TRADING LTD · Class III
Cleared under the same submission
P950027 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
- Fidia Farmaceutici
Sources (1)
- FDA UDI 28617df5-15d5-4c95-ada5-0a06f9ada64d 37 fields · synced Jun 6, 2026