Lone Star® (UDI 00888937015485)
Manufactured by CooperSurgical, Inc.
Device Regulatory Overview
The Lone Star® (Model/Catalog Number: 3311-8G) is a medical device manufactured by CooperSurgical, Inc.. This product is indexed under FDA Product Code / Category Classification V9012 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 3311-8G
- Product Code / EMDN
- V9012
- Device Name
- Lone Star Scroto-Pak™
- Database Sync Date
- 2026-08-09 16:29:16
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 Lone Star®?
The registered manufacturer of record for Lone Star® is CooperSurgical, Inc..
What is the Primary UDI-DI identifier for Lone Star®?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00888937015485.
What classification code is assigned to this device?
This device is registered under product classification code V9012.
Similar Classification Devices (V9012)
Other Devices by CooperSurgical, Inc.
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