BladeSINGLE

Basic Information

• Brand Name: BladeSINGLE
• Primary DI: 09337363001704
• Version / Model: QSBS01-B
• Company Name: QLICKSMART PTY LTD
• Labeler DUNS: 755003498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-27
• Public Version: 1
• Public Version Date: 2019-12-05
• Public Version Status: New
• Public Device Record Key: 80108a59-35b1-45e4-9e5e-965d4f6da1a5

Device Description

The Qlicksmart BladeSINGLE scalpel blade remover is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades. Used together with a hands-free passing technique, the Qlicksmart BladeSINGLE scalpel blade remover can prevent up to 5 times more injuries than a safety scalpel. This easy-to-use solution provides a low cost alternative to safety scalpels, allowing surgeons to maintain their preferences for the standard metal handle.

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: Yes
• Has Serial Number: No
• 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
GES	Blade, Scalpel	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38422	Bile duct brachytherapy system applicator, manual	A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bile duct. It is an individual device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the bile duct. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes bile duct applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09337363001704	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and avoid direct exposure to sunlight