AccessGUDID - DEVICE: EZ-Blade Remover (08800017901688)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-Blade Remover
Version or Model: EZ-Blade Remover
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DXM CO., LTD

Primary DI Number: 08800017901688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 688797315 *Terms of Use

Device Description: Disposable Blade Remover is a simple but efficient way to prevent cuts, scrapes, and possible infection when removing and disposing blades with no direct contact with the blade Easily and securely remove used scalpel blades for disposal • Palm-sized round design made with rigid and durable polypropylene • User is able to safely and hygienically remove the blades with one simple pull • Store up to 100 blades • Store not only used scalpel blades but also medical needles, dermaplaning tools, dermaplaning razors, and other small blades

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:	No
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?
46235	Scalpel blade remover	A non-powered device intended to be used to safely remove and contain scalpel blades from reusable scalpel handles after use. It is typically a sealed container into which a scalpel is pushed, whereby an internal mechanism detaches the blade from the handle; the blade is retained within the container. This device may be used in a clinical or laboratory setting. This is a single-use device.	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: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c55a0206-d889-4860-a3c6-8855bc9d0694
Public Version Date: June 27, 2023
Public Version Number: 1
DI Record Publish Date: June 19, 2023