AccessGUDID - DEVICE: BladeNeedleSYSTEM (09337363001674)

GUDID

Device Identifier (DI) Information

Brand Name: BladeNeedleSYSTEM
Version or Model: QBNS202S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: QLICKSMART PTY LTD

Primary DI Number: 09337363001674
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 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.

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?
46236	Scalpel blade remover, sterile	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAB	Needle, Suturing, Disposable

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 0cfef6e9-d660-4811-b899-ae02ee0ba604
Public Version Date: December 09, 2019
Public Version Number: 2
DI Record Publish Date: November 27, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
29337363001678	4	19337363001671	2019-12-06	Not in Commercial Distribution	Outer cartopn
19337363001671	30	09337363001674	2019-12-06	Not in Commercial Distribution	Inner box