Identity
- Trade Name
- MICROSPONGE FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- Regular TIP Opthalmic Sponge FDA UDI
- Model / Reference
- 8065100002 FDA UDI
- Description
- Regular TIP Opthalmic Sponge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380651000025 FDA UDI
- FDA Product Code
- HOZ FDA UDI
- GMDN Term
- Ophthalmic sponge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4790 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
Yes
FDA UDI
Category: Ophthalmic sponge
Microsponge by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic sponge.
- NETCELL — Network Medical Products, Ltd. · Class II
- Ultracell — Beaver-Visitec International, Inc. · Class II
- NETCELL — Network Medical Products, Ltd. · Class II
- Eyetec — Network Medical Products, Ltd. · Class II
- Visitec® — Beaver-Visitec International, Inc. · Class II
- Coronet — Network Medical Products, Ltd. · Class II
- Kitpack — Network Medical Products, Ltd. · Class II
- Ultracell — Beaver-Visitec International, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 53079b2a-fdea-4e3f-8952-32c5f0593eda 34 fields · synced May 31, 2026