imagiQ

Basic Information

• Brand Name: imagiQ
• Primary DI: 07332339232610
• Version / Model: imagiQ2 Accessory Package
• Catalog Number: 535-1790
• Company Name: Stille AB
• Labeler DUNS: 355280827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-12
• Public Version: 1
• Public Version Date: 2021-03-22
• Public Version Status: New
• Public Device Record Key: fec5c0cc-0aa0-4f59-ae5a-07c9f493481a

Device Description

Set of 6 UDI products as a convenience kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
CDG	Chromatography Separation/Zimmerman 17-Ketogenic Steroids	Clinical Chemistry	862.1385	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40658	Fluoroscopy/angiography table, powered	A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332339232610	GS1