gudid
Primary ID: 19612
New Image (UDI 19612)
Manufactured by HOLLISTER INCORPORATED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for New Image - Primary ID 19612
Device Regulatory Overview
The New Image (Model/Catalog Number: 19612) is a medical device manufactured by HOLLISTER INCORPORATED. This product is indexed under FDA Product Code / Category Classification PQE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 19612
- Product Code / EMDN
- PQE
- Device Name
- Colostomy/Illeostomy Kit, CeraPlus, Soft Convex, Drainable
- Database Sync Date
- 2026-08-09 09:57:12
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 New Image?
The registered manufacturer of record for New Image is HOLLISTER INCORPORATED.
What is the Primary UDI-DI identifier for New Image?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 19612.
What classification code is assigned to this device?
This device is registered under product classification code PQE.
Similar Classification Devices (PQE)
Other Devices by HOLLISTER INCORPORATED
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