Identity
- Trade Name
- Monovisc FDA UDI
- Generic Name
- Synovial fluid supplementation medium FDA UDI
- Device Name
- Monovisc is injected into the knee to relieve the pain of osteoarthritis. FDA UDI
- Model / Reference
- None FDA UDI
- Description
- Monovisc is injected into the knee to relieve the pain of osteoarthritis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060548950033 FDA UDI
- PMA Number
- P090031 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
Monovisc by Pavan Trading Ltd — 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
- ORTHOVISC — SAIMA GLOBAL FARMA S.L. · Class III
- Supartz — Arcera GmbH · Class III
- VISCO-3 sodium hyaluronate — Seikagaku Corp. · Class III
- Supartz — PROPHARMA-UK LTD · Class III
- Supartz — FCL HEALTH SOLUTIONS LTD · Class III
Cleared under the same submission
P090031 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
- Pavan Trading Ltd
Sources (1)
- FDA UDI b34a8e4c-59ff-4be0-807d-5a4f97598fd1 34 fields · synced Jun 1, 2026