FDA.reportPublic FDA data

Digital NeuroPort Biopotential Signal Processing System

Primary DI
00814901021411
Brand
Digital NeuroPort Biopotential Signal Processing System
Company
BLACKROCK MICROSYSTEMS, LLC
Model
13177
Catalog number
13177
Device description
Non-Sterile Digital Data Cable
Published
2021-11-24
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
GWKConditioner, Signal, Physiological
GWLAmplifier, Physiological Signal
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWKConditioner, Signal, PhysiologicalNeurology2
GWLAmplifier, Physiological SignalNeurology2
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042384000
K202174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042384000NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEMCyberkinetics, Inc. (Cki)2005-03-29GZL
K202174000Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems2021-02-10GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814901021411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814901021411008149010214118149010214110814901021411

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Feet

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18015825533support@blackrockmicro.com

Regulatory Flags#

DUNS number
827132015
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814901021541Digital NeuroPort Biopotential Signal Processing System13178131782025-02-14
00814901021558Blackrock NeuroPort Biopotential Signal Processing System7.7.0RS-00492025-02-14
00814901021466Blackrock NeuroPort Biopotential Signal Processing System7.6.0RS-00492023-05-17
00814901021459Blackrock NeuroPort Biopotential Signal Processing System7.5.2RS-0049, RS-01522022-09-27
00814901021435Digital NeuroPort Biopotential Signal Processing System12125121252022-09-20
00814901021442Digital NeuroPort Biopotential Signal Processing System12126121262022-09-20
00814901021428Blackrock NeuroPort Biopotential Signal Processing System7.5.0RS-00492022-08-11
00814901020001NeuroPort Electrode438243822016-09-23
00814901020193Blackrock NeuroPort Biopotential Signal Processing System6.5.4RS-00492016-09-23
00814901020278Blackrock NeuroPort Biopotential Signal Processing System7.0.0RS-00492017-07-05
00814901020100Blackrock NeuroPort Biopotential Signal Processing System446044602016-10-13
00814901020117Blackrock NeuroPort Biopotential Signal Processing System673567352017-02-14
00814901021527Digital NeuroPort Biopotential Signal Processing System12126121262023-12-04
00814901021534Digital NeuroPort Biopotential Signal Processing System12125121252023-12-04
00814901021497Blackrock NeuroPort Biopotential Signal Processing System7.6.1RS-00492023-07-14
00814901021473NeuroPlex E12812889128892023-05-18
00814901021480NeuroPlex E128 Sterile12890128902023-05-18
00814901020292Blackrock NeuroPort Biopotential Signal Processing System7.0.2RS-01012018-09-06
00814901020308Blackrock NeuroPort Biopotential Signal Processing System7.0.3RS-01012018-09-06
00814901020315Blackrock NeuroPort Biopotential Signal Processing System7.0.4RS-01152018-09-06

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