Identity
- Trade Name
- PROVISC FDA UDI
- Generic Name
- Aqueous/vitreous humour replacement medium kit FDA UDI
- Device Name
- PROVISC 0.40ML 27G FDA UDI
- Model / Reference
- 8065183004 FDA UDI
- Description
- PROVISC 0.40ML 27G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380651830042 FDA UDI
- FDA Product Code
- LZP FDA UDI
- GMDN Term
- Aqueous/vitreous humour replacement medium kit 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
Dimensions & Sizes
- Size
- Total Volume — 0.40 Milliliter FDA UDI
Category: Aqueous/vitreous humour replacement medium kit
Provisc by Alcon Laboratories, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (2)
- FDA UDI ba70c2c7-e6a0-4b2e-b70e-4589f3feb239 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026