Americot

FDA UDI

Class II (US FDA UDI)

by American Surgical Company, LLC

Identity

Trade Name: Americot FDA UDI
Generic Name: Cottonoid pad FDA UDI
Device Name: Americot Blue 3/8" x 2" FDA UDI
Model / Reference: 20-26S FDA UDI
Description: Americot Blue 3/8" x 2" FDA UDI

Identifiers

Primary DI / UDI-DI: 20749915000210 FDA UDI
510(k) Number: K854713 FDA UDI
FDA Product Code: HBA FDA UDI
GMDN Term: Cottonoid pad FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cottonoid pad

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

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Cleared under the same submission

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: American Surgical Company, LLC

Sources (1)

FDA UDI 0b21bf94-1770-49e7-97d2-ca09af27e6cc 34 fields · synced Jun 9, 2026