Assure® SD Sharps Container

Basic Information

• Brand Name: Assure® SD Sharps Container
• Primary DI: 00015482243012
• Version / Model: 243001
• Company Name: ARKRAY USA, INC.
• Labeler DUNS: 008171162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: c6dd41bc-5508-4768-893c-86c915d40dac

Device Description

Sharps Container for disposal of e.g. needles and syringes (3 Gallon Slide Lid Red)

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
MMK	Container, sharps	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35429	Sharps container	A hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10015482243019	GS1	Case Pack	12	In Commercial Distribution
Primary	00015482243012	GS1

Customer Contacts

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