SHARPS CONTAINER SHIELD

Basic Information

• Brand Name: SHARPS CONTAINER SHIELD
• Primary DI: 00718175003312
• Version / Model: 039-330
• Catalog Number: 039-330
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Labeler DUNS: 043833813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-31
• Public Version: 2
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 687c993a-9ed7-408b-915a-2e42c0450486

Device Description

Shield, Sharps, Container, Beta/Gamma

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: No
• 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
35430	Radioactive waste container	A hard-walled container designed for the safe deposit, collection and storage of radioactive materials including containers previously used for those materials (e.g., scintillation vials). It is made from metal and/or hard plastic and typically designed with an internal radiation shield [e.g., a lead (Pb) liner]. It typically has a lid with radiation shielding properties that allows temporary and final closure options. It is identified with a radioactive symbol on its labelling and sent to a radioactive waste treatment plant for disposal when filled to the recommended level.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00718175003312	GS1