eudamed_udi
Primary ID: 00817688021995
ESU Shroud (UDI 00817688021995)
Manufactured by I.C. Medical, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ESU Shroud - Primary ID 00817688021995
Device Regulatory Overview
The ESU Shroud (Model/Catalog Number: ICM-000-0543) is a medical device manufactured by I.C. Medical, Inc.. This product is indexed under FDA Product Code / Category Classification Z12019085 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ICM-000-0543
- Product Code / EMDN
- Z12019085
- Device Name
- ESU Shroud
- Database Sync Date
- 2026-08-09 17:48:46
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 ESU Shroud?
The registered manufacturer of record for ESU Shroud is I.C. Medical, Inc..
What is the Primary UDI-DI identifier for ESU Shroud?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00817688021995.
What classification code is assigned to this device?
This device is registered under product classification code Z12019085.
Similar Classification Devices (Z12019085)
Other Devices by I.C. Medical, Inc.
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