GUDIDData
eudamed_udi Primary ID: 10749915001388

Uniqcot (UDI 10749915001388)

Manufactured by American Surgical Company, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Uniqcot - Primary ID 10749915001388

Device Regulatory Overview

The Uniqcot (Model/Catalog Number: 67-07) is a medical device manufactured by American Surgical Company, LLC. This product is indexed under FDA Product Code / Category Classification M040799 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 ...

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Technical Specifications

Model Number
67-07
Product Code / EMDN
M040799
Device Name
Uniqcot
Database Sync Date
2026-08-09 16:50:25

Full Regulatory Attributes

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

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Frequently Asked Questions

Who is the primary manufacturer of Uniqcot?

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

What is the Primary UDI-DI identifier for Uniqcot?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10749915001388.

What classification code is assigned to this device?

This device is registered under product classification code M040799.

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