FDA.reportPublic FDA data

XactTrode Patient Cable

Primary DI
00814901021244
Brand
XactTrode Patient Cable
Company
BLACKROCK MICROSYSTEMS, LLC
Model
028916
Catalog number
028916
Device description
XactTrode Patient Cable, 48 Contact with DIN Lead Connector, 10ft
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
00814901021244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814901021244008149010212448149010212440814901021244

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
Length10Feet

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
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13
08698870325334FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325341FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325358FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325365FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325372FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870328588FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870329523FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335708FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335715FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335722FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335739FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336446FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336453FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336460FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336477FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336484FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336491FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336507FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336514FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336521FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336538FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336545FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22