FDA.report

Disposable EMG needle electrodes

Primary DI
18054655015673
Brand
Disposable EMG needle electrodes
Company
SPES MEDICA SRL
Model
TFDN451833SB
Published
2016-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications

CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18054655015673PrimaryGS10
08054655015676Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1805465501567318054655015673
08054655015676080546550156768054655015676

GMDN Terms

TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
514029771
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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