FDA.reportPublic FDA data

XactTrode Patient Cable

Primary DI
00814901021060
Brand
XactTrode Patient Cable
Company
BLACKROCK MICROSYSTEMS, LLC
Model
028898
Catalog number
028898
Device description
XactTrode Patient Cable, 10 Contact with DIN Lead Connector, 6ft
Published
2021-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191346000Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems2020-02-14GYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814901021060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814901021060008149010210608149010210600814901021060

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic signal amplifierAn electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them. It could typically be used when using an electroencephalograph (EEG).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Feet

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Hydrogen Peroxide""]"
Ethylene Oxide;Hydrogen Peroxide

Contacts#

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

Regulatory Flags#

DUNS number
827132015
Device count
1
Serial number
true
Sterilization required before use
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
00814901021411Digital NeuroPort Biopotential Signal Processing System13177131772021-11-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
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