AccessGUDID - DEVICE: BladeCASSETTE (09337363000516)

GUDID

Device Identifier (DI) Information

Brand Name: BladeCASSETTE
Version or Model: QSSVCAS-BY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: QLICKSMART PTY LTD

Primary DI Number: 09337363000516
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 755003498 *Terms of Use

Device Description: The BladeCASSETTE 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 BladeCASSETTE 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. Qlicksmart BladeCASSETTE scalpel blade remover is award-winning, which demonstrate its practicality and effectiveness in reducing scalpel injuries.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38422	Bile duct brachytherapy system applicator, manual	A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bile duct. It is an individual device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the bile duct. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes bile duct applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GES	Blade, Scalpel

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry and avoid direct exposure to sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7c4c230-45b8-4d16-bf09-83f7c90b06d4
Public Version Date: December 09, 2019
Public Version Number: 2
DI Record Publish Date: November 27, 2019