Identity
- Trade Name
- Orthovisc FDA UDI
- Generic Name
- Synovial fluid supplementation medium FDA UDI
- Device Name
- Mitek Orthovisc, 2 mL, US FDA UDI
- Model / Reference
- 630254 FDA UDI
- Description
- Mitek Orthovisc, 2 mL, US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817337000111 FDA UDI
- PMA Number
- P030019 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
Orthovisc by Anika Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- VISCO-3 sodium hyaluronate — Seikagaku Corp. · Class III
- Synvisc One (Synvisc Three) — PAVAN TRADING LTD · Class III
Cleared under the same submission
P030019 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
- Anika Therapeutics, Inc.
Sources (1)
- FDA UDI 6c4c2984-2a1d-4daf-bef3-c54ea0e5dd12 35 fields · synced Jun 9, 2026