Identity
- Trade Name
- PRO-PAKS®️ FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- ULTRA Premium PVA Lasik Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. Our ULTRA PREMIUM Spears are 100% lint free. 15 Tyvek Pouches of 10 each (2 foils). FDA UDI
- Model / Reference
- MK-108 FDA UDI
- Description
- ULTRA Premium PVA Lasik Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. Our ULTRA PREMIUM Spears are 100% lint free. 15 Tyvek Pouches of 10 each (2 foils). FDA UDI
Identifiers
- Catalog Number
- MK-108 FDA UDI
- Primary DI / UDI-DI
- 10810003220032 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
Category: Ophthalmic sponge
Pro-Paks®️ by Microspecialities, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Microspecialities, Inc.
Sources (1)
- FDA UDI 6c1bd462-563e-4b3d-8ba1-ad597e415612 35 fields · synced May 30, 2026