Adora Accessory

Basic Information

• Brand Name: Adora Accessory
• Primary DI: 05713464000640
• Version / Model: 04282200
• Company Name: Nrt - Nordisk Røntgen Teknik A/S
• Labeler DUNS: 307332705
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-16
• Public Version: 1
• Public Version Date: 2025-09-24
• Public Version Status: New
• Public Device Record Key: d9dbb0e9-1429-4344-b6c5-de1ff0b278ca

Device Description

Mattress, 3 cm for the Adora DRFi X-ray system for optimizing patient comfort when lying on table.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35183	Basic bed mattress	A large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713464000640	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K242948	000