FDA.reportPublic FDA data

BladeNeedleSYSTEM

Primary DI
09337363001674
Brand
BladeNeedleSYSTEM
Company
QLICKSMART PTY LTD
Model
QBNS202S
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.
Published
2019-11-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19337363001671PackageGS130Not in Commercial Distribution
29337363001678PackageGS14Not in Commercial Distribution
09337363001674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933736300167119337363001671
2933736300167829337363001678
09337363001674093373630016749337363001674

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade remover, sterileA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and avoid direct exposure to sunlight

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
755003498
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09337363001834BladeFlask EVOQBVRMOPEC2023-06-23
09337363001841BladeFlask EVOQBVRGEN2023-06-23
29337363001838BladeFlask EVOQBVRMOPEC2023-06-23
29337363001845BladeFlask EVOQBVRGEN2023-06-23
09337363001209BladeFLASKQFRGEN2016-10-24
09337363001216BladeFLASKQFRGEN-012016-10-24
09337363001223BladeFLASKQFRUSAMOPEC2016-10-24
09337363001230BladeFLASKQFRUSAHAV2016-10-24
09337363001766BladeFlask EVO Blade RemoverQBVRGEN2021-01-27
09337363001780BladeFlask EVO Blade RemoverQBVRMOPEC2021-01-27
09337363001322Qlicksmart SnapIT Lite Large BurgundySN-02L2018-03-19
09337363001339Qlicksmart SnapIT Lite Regular GreySN-02RSN-02R2018-03-19
09337363001346Qlicksmart SnapIT Lite Regular PinkSN-02RSN-02Rpk2018-03-19
09337363001353Qlicksmart SnapIT Lite Regular BlueSN-02RSN-02Rb2018-03-19
09337363001360Qlicksmart SnapIT Lite Regular PurpleSN-02RSN-02Rpp2018-03-19
09337363001377Qlicksmart SnapIT Lite Blue with Boehringer Ingelheim LogoSN-02R-Bi2019-02-19
09337363001384Qlicksmart SnapIT Lite Grey with Cincinnati LogoSN-02R-Cc2019-02-19
09337363001513Qlicksmart SnapIT Trolley Extra LargeTE-01XL2019-03-22
09337363001520Qlicksmart SnapIT Regular BlueSN-01RSN-01Rb2018-03-19
09337363001537Qlicksmart SnapIT Regular PurpleSN-01RSN-01Rp2018-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918121994AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-04-06
16931918157016AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
16931918179858AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
16931918144948AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
10192253052329DevonCardinal Health 200, LLCGAB2025-05-29
10192253052138DevonCardinal Health 200, LLCGAB2025-03-27
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10192253052152DevonCardinal Health 200, LLCGAB2025-03-27
10192253052169DevonCardinal Health 200, LLCGAB2025-03-27
10192253052176DevonCardinal Health 200, LLCGAB2025-03-27
10192253052183DevonCardinal Health 200, LLCGAB2025-03-27
10192253052190DevonCardinal Health 200, LLCGAB2025-03-27
10192253052206DevonCardinal Health 200, LLCGAB2025-03-27
10192253052213DevonCardinal Health 200, LLCGAB2025-03-27
10192253052220DevonCardinal Health 200, LLCGAB2025-03-27
10192253052237DevonCardinal Health 200, LLCGAB2025-03-27
10192253052244DevonCardinal Health 200, LLCGAB2025-03-27
10192253052251DevonCardinal Health 200, LLCGAB2025-03-27
10192253052268DevonCardinal Health 200, LLCGAB2025-03-27
10192253052275DevonCardinal Health 200, LLCGAB2025-03-27
10192253052282DevonCardinal Health 200, LLCGAB2025-03-27
10192253052299DevonCardinal Health 200, LLCGAB2025-03-27
10192253052312DevonCardinal Health 200, LLCGAB2025-03-27
10192253052336DevonCardinal Health 200, LLCGAB2025-03-27
10192253052343DevonCardinal Health 200, LLCGAB2025-03-27
10192253052350DevonCardinal Health 200, LLCGAB2025-03-27
10192253052367DevonCardinal Health 200, LLCGAB2025-03-27
10192253052374DevonCardinal Health 200, LLCGAB2025-03-27
10192253052381DevonCardinal Health 200, LLCGAB2025-03-27
10192253053357DevonCardinal Health 200, LLCGAB2025-03-27