gudid
Primary ID: XRK1P-12-10
DOUBLE FLEECE (UDI XRK1P-12-10)
Manufactured by Royal Knit, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DOUBLE FLEECE - Primary ID XRK1P-12-10
Device Regulatory Overview
The DOUBLE FLEECE (Model/Catalog Number: XRK1P-12-10) is a medical device manufactured by Royal Knit, Inc.. This product is indexed under FDA Product Code / Category Classification FQL within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- XRK1P-12-10
- Product Code / EMDN
- FQL
- Device Name
- (8"-12") Double Fleece 1 Ply Silver Medium No Hole
- Database Sync Date
- 2026-08-09 09:03:54
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 DOUBLE FLEECE?
The registered manufacturer of record for DOUBLE FLEECE is Royal Knit, Inc..
What is the Primary UDI-DI identifier for DOUBLE FLEECE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is XRK1P-12-10.
What classification code is assigned to this device?
This device is registered under product classification code FQL.
Similar Classification Devices (FQL)
Other Devices by Royal Knit, Inc.
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