eudamed_udi Primary ID: 10749915000688

Cotton Balls (UDI 10749915000688)

Manufactured by American Surgical Company, LLC

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Cotton Balls (Model/Catalog Number: 31-07) is a medical device manufactured by American Surgical Company, LLC. This product is indexed under FDA Product Code / Category Classification M0299 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0287-2025 View Full Alert →

Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

Technical Specifications

Model Number: 31-07
Product Code / EMDN: M0299
Device Name: Cotton Balls
Database Sync Date: 2026-08-09 19:01:02

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Cotton Balls?

The registered manufacturer of record for Cotton Balls is American Surgical Company, LLC.

What is the Primary UDI-DI identifier for Cotton Balls?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10749915000688.

What classification code is assigned to this device?

This device is registered under product classification code M0299.

Similar Classification Devices (M0299)

Other Devices by American Surgical Company, LLC

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint