BladeFlask EVO

Basic Information

• Brand Name: BladeFlask EVO
• Primary DI: 09337363001841
• Version / Model: QBVRGEN
• Company Name: QLICKSMART PTY LTD
• Labeler DUNS: 755003498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: ece7bbd2-ce8d-4e93-9ca6-613f9b172271

Device Description

The Qlicksmart BladeFlask EVO provides a simply safer way to remove used scalpel blades and can accommodate different types of scalpel handles and blades including large autopsy scalpels, thick and round handles, even hexagonal shaped versions - giving you greater freedom in using any scalpel you want. It is so simple to use with just one hand. Embrace safety with the new standard in scalpel blade removals and prevent the dangerous injuries commonly caused by removing blades with fingers, forceps or re-sheathing. BladeFlask EVO is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades.

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
46235	Scalpel blade remover	A non-powered device intended to be used to safely remove and contain scalpel blades from reusable scalpel handles after use. It is typically a sealed container into which a scalpel is pushed, whereby an internal mechanism detaches the blade from the handle; the blade is retained within the container. This device may be used in a clinical or laboratory setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	29337363001845	GS1		24	In Commercial Distribution
Primary	09337363001841	GS1

Premarket Submissions

Submission Number	Supplement Number
K213274	000