IMAGE DIAGNOSTICS, INC

Basic Information

• Brand Name: IMAGE DIAGNOSTICS, INC
• Primary DI: 00850061871107
• Version / Model: FEMORAL SHIELD RADIATION SHIELD PAD
• Catalog Number: X800-0251
• Company Name: IMAGE DIAGNOSTICS, INC.
• Labeler DUNS: 608235214
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2024-10-23
• Public Version: 1
• Public Version Date: 2024-10-31
• Public Version Status: New
• Public Device Record Key: 6fd5f6dd-20bf-4d3d-9b55-21f20aad55e5

Device Description

IDI,PROTEGO,PAD,SCATTER SHIELD,FEMORAL,CASE OF 15,#X800-0251

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPY	Shield, Protective, Personnel	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
Unit of Use	00850061871091	GS1
Primary	00850061871107	GS1

Customer Contacts

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