FDA.report

Sanibel

Primary DI
05711117199352
Brand
Sanibel
Company
Interacoustics A/S
Model
Snap electrode
Device description
Pouch of 60 electrodes
Published
2018-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05711117199352PrimaryGS10
05711117199086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05711117199352057111171993525711117199352
05711117199086057111171990865711117199086

GMDN Terms

TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
306308354
Device count
5
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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05711117027600AmplivoxAssortment box Amplivox 2022-12-08
05711117099027MaicoAssortment Box 11712022-12-08
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05711117221305Sanibel SupplySnapPROBE™ Accessories box2022-12-08
05711117123487Sanibel SupplyEar tip infant 4 mm, ANA-4.0, blue2022-12-08
05711117123494Sanibel SupplyEar tip infant 5 mm, ANA-5.0, green2022-12-08
05711117123470Sanibel SupplyEar tip infant 4,5 mm, ANA-4.5, red-brown2022-12-08

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