FDA.reportPublic FDA data

Tecnibrands

Primary DI
00182097000023
Brand
Tecnibrands
Company
TECNIMED SRL
Model
Click
Device description
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite ItchNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130019000ZANZA-CLICKTecnimed S.R.L.2014-11-07OSG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00182097000313PackageGS1320In Commercial Distribution
00182097000023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00182097000313001820970003131820970003130182097000313
00182097000023001820970000231820970000230182097000023

GMDN Terms#

Term, Definition table
TermDefinition
Insect bite/sting electrical stimulatorA portable, manual 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
445878788
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00182097000177Tecnimed - BV MedicalVisioFocus 06400064002017-03-10
00182097000238Tecnimed - Handi-Craft CompanyVisioFocus SMART064702017-06-27
00182097000689Tecnimed - HammacherVisioFocus064002021-01-20
00182097000696Tecnimed - HammacherVisioFocus064002021-01-20
00182097000078Tecnimed - BV MedicalThermofocus 08000800H52016-09-12
00182097000559TECNIMED - Medline Industries, IncVisioFocus PRO 06480064802020-08-11
00182097000511Tecnimed VisioFocus PRO 06480064802020-06-04
00182097000474Tecnimed - BV MedicalVisioFocus PRO 06480064802020-04-13
00182097000498TECNIMED - Hopkins Medical ProductsVisioFocus PRO 06480064802020-04-13
00182097000429Tecnimed - 3J MEDICAL SUPPLIES IncVisioFocus MINI067002019-09-10
00182097000436Tecnimed - 3J MEDICAL SUPPLIES IncVisioFocus064002019-09-10
00182097000443Tecnimed - 3J MEDICAL SUPPLIES IncVisioFocus PRO064802019-09-10
00182097000054Tecnimed - BV MedicalThermofocus 07000700A22016-09-12
00182097000061Tecnimed - BV MedicalThermofocus 0150001500A32016-09-12
00182097000139Hopkins Medical ProductsTouch-Free ThermometerThermofocus 01500A32016-09-20
00182097000153TECNIMED - Hopkins Medical ProductsVisioFocus 06400064002017-02-17
00182097000191Tecnimed - Constant Care TechnologyThermofocus 08002017-03-30
00182097000351TecnimedVisioFocus MINI067002018-07-30
00182097000368TECNIMEDDisc-o-Click2018-05-15
00182097000382TECNIMEDDisc-o-Click2018-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044118946iHealthiHealth Labs Inc.OSG2026-04-16
00311917206721WalgreensWALGREEN CO.OSG2018-12-21
00182097000412WalgreensWALGREEN CO.OSG2018-12-21
00182097000368TECNIMEDTECNIMED SRLOSG2018-05-15
00182097000382TECNIMEDTECNIMED SRLOSG2018-05-15