AccessGUDID - DEVICE: TECNIMED (00182097000368)

GUDID

Device Identifier (DI) Information

Brand Name: TECNIMED
Version or Model: Disc-o-Click
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECNIMED SRL

Primary DI Number: 00182097000368
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 445878788 *Terms of Use

Device Description: Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.

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?
59437	Insect bite/sting electrical stimulator	A portable device intended to be used for the external treatment of insect bites or stings (e.g., from mosquitoes) through dispatch of a small (e.g., 13 kV) piezeoelectric charge to the affected region of the skin. The charge is intended to localize the poison and inhibit histamine release therefore reducing itching and inflammation. It typically consists of a pocket-sized, hand-held housing containing piezocrystal with a trigger mechanism. It is available [non-prescription] over-the-counter (OTC) for home-use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSG	Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

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
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eaf07fc9-8112-4c05-87f0-1f617ea52f3c
Public Version Date: August 20, 2020
Public Version Number: 4
DI Record Publish Date: May 15, 2018