IMAGE DIAGNOSTICS, INC

Basic Information

• Brand Name: IMAGE DIAGNOSTICS, INC
• Primary DI: 00850977007775
• Version / Model: Compass Frame Stand-Alone Unit
• Catalog Number: A610-0215
• Company Name: IMAGE DIAGNOSTICS, INC.
• Labeler DUNS: 608235214
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-08
• Public Version: 1
• Public Version Date: 2021-03-16
• Public Version Status: New
• Public Device Record Key: 984ad7b7-4f60-470a-a3f9-c986a2e4ad42

Device Description

IDI,RADIATION PROTECTION SYSTEM,LEADED ACRYLIC WINDOW,STAND-ALONE,COMPASS FRAME,#A610-0215

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: Yes
• 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
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38373	Radiation shielding panel, portable/mobile	A portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850977007775	GS1

Customer Contacts

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