Hollister (UDI 00610075068500)
Manufactured by Hollister Incorporated
Device Regulatory Overview
The Hollister (Model/Catalog Number: 11016) is a medical device manufactured by Hollister Incorporated. This product is indexed under FDA Product Code / Category Classification U01010502 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
- 11016
- Product Code / EMDN
- U01010502
- Device Name
- Urethral Intermittent Catheter, Nelaton
- Database Sync Date
- 2026-08-09 16:29:31
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 Hollister?
The registered manufacturer of record for Hollister is Hollister Incorporated.
What is the Primary UDI-DI identifier for Hollister?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00610075068500.
What classification code is assigned to this device?
This device is registered under product classification code U01010502.
Similar Classification Devices (U01010502)
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