Identity
- Trade Name
- Alcon Eye-Pak FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- Eye Pak* 1062 Non-woven Ophthalmic Drape INCISE FDA UDI
- Model / Reference
- 8065106220 FDA UDI
- Description
- Eye Pak* 1062 Non-woven Ophthalmic Drape INCISE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380651062207 FDA UDI
- FDA Product Code
- HMT FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not 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
Alcon Eye-Pak by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI be342b6f-a90f-4dde-a4cb-a2f05890c4e8 35 fields · synced Jun 7, 2026