FDA.reportPublic FDA data

Seer Home

Primary DI
19355751001218
Brand
Seer Home
Company
SEER MEDICAL HOLDINGS LIMITED
Model
SM-07-8001
Device description
Disposable EEG Wires
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19355751001218PackageGS112In Commercial Distribution
09355751001211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1935575100121819355751001218
09355751001211093557510012119355751001211

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp leadA wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 288-5045info@seermedical.com

Regulatory Flags#

DUNS number
744473197
Device count
1
DM exempt
false
Premarket exempt
true
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
09355751001242Seer HomeSeer Cloud2024-06-27
09355751001174Seer HomeSM-01-80012024-06-27
09355751001181Seer HomeSM-03-8001-INT2024-06-27
09355751001228Seer HomeMonitoring Portal2024-06-27
09355751001235Seer HomeSeer App: Epilepsy Management2024-06-27
09355751001037Seer HomeSM-03-8001-INT2023-09-14
09355751001136Seer HomeMonitoring Portal2023-09-05
09355751001020Seer HomeSM-01-80012023-09-04
09355751001051Seer HomeSeer App: Epilepsy Management2023-09-04
09355751001211Seer HomeSM-07-80012024-06-27
09355751001259Seer HomeSM-01-90082024-06-27
09355751001266Seer HomeSM-01-90052024-06-27
09355751001105Seer HomeSM-01-90082023-09-14
09355751001099Seer HomeSM-01-9003-US2023-09-05
09355751001112Seer HomeSM-01-90052023-09-05
09355751001129Seer HomeSM-07-80012023-06-21
09355751001273Seer HomeSM-01-90082024-06-27
09355751001044Seer HomeSeer Cloud2023-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572108APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572115APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572122APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725571712APKAPK Technology Co.,Ltd.IKD2026-07-01
06946725500866APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500873APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500880APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500897APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500903APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500910APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500927APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500934APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500941APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500958APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500965APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500972APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22