Identity
- Trade Name
- Pro-Paks FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- Lasik Shield, 20/bx. Our effective synthetic PVA shields are highly absorbent allowing aqueous solutions to be wicked up quickly. FDA UDI
- Model / Reference
- MK-501-8mm FDA UDI
- Description
- Lasik Shield, 20/bx. Our effective synthetic PVA shields are highly absorbent allowing aqueous solutions to be wicked up quickly. FDA UDI
Identifiers
- Catalog Number
- MK-501-8mm FDA UDI
- Primary DI / UDI-DI
- 10810003221978 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDI
Category: Ophthalmic sponge
Pro-Paks by Microspecialities, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic sponge.
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- 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 |
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Manufacturer
- Manufacturer
- Microspecialities, Inc.
Sources (1)
- FDA UDI f6d9e0af-9b91-46e5-8b5c-9eeb89c9080e 36 fields · synced May 30, 2026