FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08436560853152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08436560853152084365608531528436560853152

GMDN Terms

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

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

Sterilization Methods

Method

Regulatory Flags

DUNS number
467087078
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08436560853169ToskaniNFTKN-00-03162025-12-12

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