BladeNeedleSYSTEM

Basic Information

• Brand Name: BladeNeedleSYSTEM
• Primary DI: 09337363001681
• Version / Model: QBNS202S-R
• 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: 2c162c3f-1b22-4aa9-9af1-a9de42b6b440

Device Description

The Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count and efficient disposal of both scalpel blades and suture needles.

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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46236	Scalpel blade remover, sterile	A sterile device used to safely remove and contain one scalpel blade from a reusable scalpel handle without compromising the sterility of a surgical field. It is typically a sealed plastic cartridge into which a scalpel is pushed, and where an internal configuration transforms this linear motion into a lateral force that lifts the heel (rear portion) of the scalpel blade from the tang of the handle, and a reverse linear motion (pulling the scalpel handle out) removes the blade from the tang; the blade is retained within the container. This device may have a dedicated holder and is typically used in surgical facilities. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	29337363001685	GS1	Outer carton	4	In Commercial Distribution
Package	19337363001688	GS1	Inner box	30	In Commercial Distribution
Primary	09337363001681	GS1

Storage Conditions

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