FDA.reportPublic FDA data

BladeSINGLE

Primary DI
09337363001698
Brand
BladeSINGLE
Company
QLICKSMART PTY LTD
Model
QSBS01
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.
Published
2019-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GESBlade, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19337363001695PackageGS1300In Commercial Distribution
29337363001692PackageGS14In Commercial Distribution
09337363001698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933736300169519337363001695
2933736300169229337363001692
09337363001698093373630016989337363001698

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
14250368861406KURZ Precise BladesHeinz Kurz GmbHGES2026-05-21
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
10888277384224MEDLINEMEDLINE INDUSTRIES, INC.GES2025-02-14
10888277391857MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-30
10888277383395MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10888277385115MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10850053289818SurgycoSurgyco LLCGES2024-12-20
10850053289825SurgycoSurgyco LLCGES2024-12-20
10850053289832SurgycoSurgyco LLCGES2024-12-20
10850053289849SurgycoSurgyco LLCGES2024-12-20
10850053289856SurgycoSurgyco LLCGES2024-12-20
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