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Ophthalmic Pledget

FDA UDI

Class II (US FDA UDI)

by American Surgical Company, LLC

Identity

Trade Name
Ophthalmic Pledget FDA UDI
Generic Name
Cotton wool ball, sterile FDA UDI
Device Name
Ophthalmic Pledget 7/32" FDA UDI
Model / Reference
111-02 FDA UDI
Description
Ophthalmic Pledget 7/32" FDA UDI

Identifiers

Catalog Number
111-02 FDA UDI
Primary DI / UDI-DI
20749915002566 FDA UDI
FDA Product Code
HOZ FDA UDI
GMDN Term
Cotton wool ball, sterile 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

No

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

No

FDA UDI

Category: Cotton wool ball, sterile

Ophthalmic Pledget by American Surgical Company, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cotton wool ball, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Surgical Company, LLC

Sources (1)

  • FDA UDI 1867658a-0f08-44d2-827d-184760eee42e 34 fields · synced Jun 9, 2026