AccessGUDID - DEVICE: Nuaskin Skin Tag Remover (00860003125588)

GUDID

Device Identifier (DI) Information

Brand Name: Nuaskin Skin Tag Remover
Version or Model: FY-111
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00860003125588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: For use on: Skin Vegetations Fatty Grains Freckles Age Spots Warts Verruca Large Moles Large Freckles

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):	Yes
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?
13472	Scarifier	A hand-held manual surgical instrument consisting of many sharp points or cutting blades intended to be used to produce many small, superficial scratches or punctures in the skin, as for the introduction of smallpox vaccine. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MIJ	Needle, Tumor Localization

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de7e31a0-f6d0-4c78-bfaf-d9f5a0a4e984
Public Version Date: December 03, 2020
Public Version Number: 1
DI Record Publish Date: November 25, 2020