Adora Accessory

Basic Information

• Brand Name: Adora Accessory
• Primary DI: 05713464000695
• Version / Model: 04289500
• 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: 88e8bb87-53e6-4d51-b771-bf1740b9fa12

Device Description

Patient table support for Patient CPR For the Adora DRFi X-ray system. A table stabilizer intended to give support to the patient table in case of emergency CPR purposes.

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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
62758	Medical table top floor stand, non-powered	A non-powered device designed to support and stabilize from the floor a medical table top [e.g., an operating table top for hand surgery, or a table top for cardiopulmonary resuscitation (CPR)] or table [e.g., base of a traction table]. It may be in the form of a slender vertical telescopic post, a framework or a multi-jointed structure, and is typically used for support of cantilevered table tops or extensions; it is not intended to function as the primary support for the main body of an operating table top (i.e., not an operating table base).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713464000695	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K242948	000