Sanibel

Primary DI
05711117199338
Brand
Sanibel
Company
Interacoustics A/S
Model
Snap electrode
Published
2018-02-08
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

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711117199338PrimaryGS10
05711117199116Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711117199338057111171993385711117199338
05711117199116057111171991165711117199116

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711117244991InteracousticsVisualEyes 5052025-08-14
05711117245004InteracousticsVisualEyes EyeSeeCam vHIT2025-08-14
05711117245028InteracousticsVisualEyes 5252025-08-14
05711117245097Sanibel Supply A/SER10C-0385372382025-08-07
05711117245103Sanibel Supply A/SER10C-0485372392025-08-07
05711117245110Sanibel Supply A/SER10C-0585372402025-08-07
05711117245127Sanibel Supply A/SER10C-0685372412025-08-07
05060488903106AmplivoxEar tips 8-15 mm mushroom2022-12-08
05711117086447Sanibel SupplyEar tip, OAE-4 ER Infant, 4 mm red flanged2022-12-08
05711117026504Sanibel SupplyAssortment Box BET252022-12-08
05711117027600AmplivoxAssortment box Amplivox 2022-12-08
05711117099027MaicoAssortment Box 11712022-12-08
05711117106565MaicoAudiometric ear tip80293062022-12-29
05711117141658Sanibel SupplySanibel ADI Scre. Ear Tip Kit2022-12-08
05711117198256Sanibel SupplySanibelâ„¢ ADI Ear Tip Kit2022-12-08
05711117211658Sanibel SupplyAssortment BET55 Complete2022-12-08
05711117221305Sanibel SupplySnapPROBEâ„¢ 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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