Identity
- Trade Name
- Amvisc FDA UDI
- Generic Name
- Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
- Device Name
- AMVISC 0.8ML FDA UDI
- Model / Reference
- 59081L FDA UDI
- Description
- AMVISC 0.8ML FDA UDI
Identifiers
- Catalog Number
- 59081L FDA UDI
- Primary DI / UDI-DI
- 00757770495658 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 by Bausch & Lomb Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bausch & Lomb Incorporated
Sources (1)
- FDA UDI 53050380-5b60-4a3b-ad7c-9d55c2b4abab 34 fields · synced Jun 6, 2026