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Pro-Paks

FDA UDI

Class II (US FDA UDI)

by Microspecialities, Inc.

Identity

Trade Name
Pro-Paks FDA UDI
Generic Name
Ophthalmic sponge FDA UDI
Device Name
Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. 15 per box with 10 pieces each. FDA UDI
Model / Reference
MK-100 FDA UDI
Description
Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. 15 per box with 10 pieces each. FDA UDI

Identifiers

Primary DI / UDI-DI
10810003224412 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

Yes

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

Similar devices

Also classified as Ophthalmic sponge.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 7f6c6c62-ab85-4d24-b550-0378f0008a7f 34 fields · synced May 30, 2026