FDA.reportPublic FDA data

Integra®

Primary DI
M272ECCF481
Brand
Integra®
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
ECCF48
Device description
The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through 6 Cam Lock cylindrical Connectors. It has 48 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels.
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780036906PrimaryGS10
M272ECCF481SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003690610381780036906

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp leadA wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN COOL DRY PLACE

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
531408342
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780035602Integral Drainage Set910410B910410B2015-10-01
M2729105001Integra®9105002016-08-08
10381780034247Lumbar Catheter9511039511032015-10-01
10381780034582CSF Reservoir9993019993012015-10-01
10381780034599CSF Reservoir9993029993022015-10-01
10381780034605CSF Reservoir9993039993032015-10-01
10381780034612CSF Reservoir9993049993042015-10-01
M27217185C121Integra®17185C122016-08-12
M27217185C161Integra®17185C162016-08-12
M27217185C321Integra®17185C322016-08-12
M27217185C481Integra®17185C482016-08-12
M27217185C641Integra®17185C642016-08-12
M27240M191Integra®40M192016-08-12
M27240M201Integra®40M202016-08-12
M27240M411Auragen™40M412016-08-08
M27240M421Auragen™40M422016-08-08
M27240M431Auragen™40M432016-08-08
M27240M451Auragen™40M452016-08-08
M27240M461Auragen™40M462016-08-08
M27240M471Auragen™40M472016-08-08

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Primary DI, Brand, Company table
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20885380202480KendallCardinal Health 200, LLCIKD2026-03-20
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