AMPatch Stoma Cover (UDI GB with 1 1/8" Hole)
Manufactured by Austin Medical Products, Inc.
Device Regulatory Overview
The AMPatch Stoma Cover (Model/Catalog Number: GB with 1 1/8" Hole) is a medical device manufactured by Austin Medical Products, Inc.. This product is indexed under FDA Product Code / Category Classification EXE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GB with 1 1/8" Hole
- Product Code / EMDN
- EXE
- Device Name
- Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
- Database Sync Date
- 2026-08-09 09:33:17
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 AMPatch Stoma Cover?
The registered manufacturer of record for AMPatch Stoma Cover is Austin Medical Products, Inc..
What is the Primary UDI-DI identifier for AMPatch Stoma Cover?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GB with 1 1/8" Hole.
What classification code is assigned to this device?
This device is registered under product classification code EXE.
Similar Classification Devices (EXE)
Other Devices by Austin Medical Products, Inc.
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