FDA.reportPublic FDA data

neon12

Primary DI
05391530950008
Brand
neon12
Company
INCEREB LIMITED
Model
TF01
Device description
EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151576000Neon EEGIncereb, Ltd.2015-09-29GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530950015PackageGS15In Commercial Distribution
05391530950022PackageGS14In Commercial Distribution
05391530950008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530950015053915309500155391530950015
05391530950022053915309500225391530950022
05391530950008053915309500085391530950008

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+35316852245pphillips@incereb.com

Regulatory Flags#

DUNS number
985065024
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530950343N10 NeuroBellTF092026-02-16
05391530950367N10 NeuroBellTF092026-02-16
05391530950039neon8TF042016-09-19
05391530950077neon8TF042022-01-16
05391530950107Neon8 KITTF04K2022-03-24
05391530950091Neon 12 KITTF01K2022-03-24
05391530950121Neon8 KITTF04K2022-03-24
05391530950084neon8TF042022-01-16
05391530950022neon12TF012016-09-19
05391530950053neon8TF042016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
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00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08