Identity
- Trade Name
- Amvisc Plus FDA UDI
- Generic Name
- Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
- Device Name
- 0.8 ml, 1.6% Sodium Hyaluronate FDA UDI
- Model / Reference
- 655-806 FDA UDI
- Description
- 0.8 ml, 1.6% Sodium Hyaluronate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07391899830605 FDA UDI
- FDA Product Code
- LZP FDA UDI
- GMDN Term
- Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.4275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Vitreous/aqueous humour replacement medium, intraoperative
Amvisc Plus by Anika Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vitreous/aqueous humour replacement medium, intraoperative.
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- HEALON ENDOCOAT PRO — Johnson & Johnson Surgical Vision, Inc. · Class III
- HEALON PRO — Johnson & Johnson Surgical Vision, Inc. · Class III
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 0c5101fe-b134-4001-b299-da444a98292c 33 fields · synced Jun 9, 2026