LEAD LINED

Basic Information

• Brand Name: LEAD LINED
• Primary DI: 00718175002742
• Version / Model: 244-006
• Catalog Number: 244-006
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Labeler DUNS: 043833813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-16
• Public Version: 1
• Public Version Date: 2019-10-24
• Public Version Status: New
• Public Device Record Key: 962f3e63-b7c1-4d69-b8da-abe15c6bd264

Device Description

SAFE, STORAGE, 2" LEAD

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
KPY	Shield, Protective, Personnel	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38381	Radiation protection safe	A lockable shielded radiation protective container intended to store radionuclide sources and materials in order to prevent their use by unauthorized individuals. Depending on the intended use, it incorporates shielding materials with appropriate attenuation characteristics that prevent exposure to persons from radiation emitted from the sources stored inside the safe.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00718175002742	GS1