AccessGUDID - DEVICE: BladeCARTRIDGE-1 (19337363001626)

GUDID

Device Identifier (DI) Information

Brand Name: BladeCARTRIDGE-1
Version or Model: QSSVCAT-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: QLICKSMART PTY LTD

Primary DI Number: 19337363001626
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 350
Labeler D-U-N-S® Number*: 755003498 *Terms of Use

Device Description: BladeCARTRIDGE is available as an add-on to the Qlicksmart BladeNeedleSYSTEM if you need more scalpel blade removers in this needle holder.

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
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: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry, Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56244c1d-fce2-4955-a9d1-389dda6d79e6
Public Version Date: October 15, 2018
Public Version Number: 1
DI Record Publish Date: September 12, 2018