FDA.reportPublic FDA data

Toskani

Primary DI
08436560853152
Brand
Toskani
Company
TOSKANI SL.
Model
WNE-01
Catalog number
TKN-00-0315
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436560853152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436560853152084365608531528436560853152

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to extreme temperature variations Store in a clean, dry environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
467087078
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436560853169ToskaniNFTKN-00-03162025-12-12

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Primary DI, Brand, Company table
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