Uniqcot (UDI 10749915001388)
Manufactured by American Surgical Company, LLC
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.
Enforcement actions are currently active for this product line.
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 ...
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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Get API Token Access ($49/mo)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.
Similar Classification Devices (M040799)
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