FDA.reportPublic FDA data

BladeSINGLE

Primary DI
29337363001692
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
Rx
false
OTC
false
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
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

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Primary DI, Brand, Company table
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