FDA.reportPublic FDA data

CERVELLO STIM

Primary DI
00850154007062
Brand
CERVELLO STIM
Company
BLACKROCK NEUROMED, LLC
Model
NM-0353
Catalog number
NM-0353
Device description
Cortical / Intracranial Stimulator to be combined with CERVELLO 64 Series Amplifiers
Published
2016-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYCElectrode, Cortical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYCElectrode, CorticalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850154007062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850154007062008501540070628501540070620850154007062

GMDN Terms#

Term, Definition table
TermDefinition
Cortical electrodeA sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-994-5661support@blackrockneuromed.com

Regulatory Flags#

DUNS number
069799474
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850154007086CERVELLO SOFTWARERS-0003RS-00032016-12-06
00850154007079MORPHEUSNM-0354NM-03542016-12-07
00850154007000CERVELLO 32751175112016-07-15
00850154007017CERVELLO 64752375232016-12-05
00850154007024CERVELLO 32 WNM-0261NM-02612016-12-06
00850154007031CERVELLO 64 WNM-0262NM-02622016-12-06
00850154007048JB CERVELLO 32751275122016-12-06
00850154007055JB CERVELLO 64752475242016-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006633CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006640CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006657CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006664CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006671CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006688CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006695CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006114CORTAC®PMT CORPORATIONGYC2026-05-18
00650551005858CORTACPMT CORPORATIONGYC2026-05-15
00650551005902CORTACPMT CORPORATIONGYC2026-05-15
00650551005964CORTAC®PMT CORPORATIONGYC2026-05-15
00840067103029ZenithCADWELL INDUSTRIES, INC.GYC2025-12-31
00848530106195Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
10848530106192Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
00850011306338ATLAS Stim Headbox - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306345ATLAS Stim Headbox - High DensityNEURALYNX, INC.GYC2025-06-11
00850011306703ATLAS Stim Headbox SoftwareNEURALYNX, INC.GYC2025-06-11
00850011306710Fiber Optic Connector 2mNEURALYNX, INC.GYC2025-06-11
00850011306727Fiber Optic Connector 7mNEURALYNX, INC.GYC2025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNEURALYNX, INC.GYC2025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityNEURALYNX, INC.GYC2025-06-11
00867718000285ATLAS Stim Headbox - NKNEURALYNX, INC.GYC2025-06-11
00848530106249Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
10848530106246Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
00848530093693Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-05-19
00650551005445CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005452CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005469CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005476CORTAC®PMT CORPORATIONGYC2025-04-25