FDA.reportPublic FDA data

BladeNeedleSYSTEM

Primary DI
29337363001678
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
Rx
false
OTC
false
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10192253052145DevonCardinal Health 200, LLCGAB2025-03-27
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