FDA.reportPublic FDA data

NeuroPace® Depth Lead Kit

Primary DI
00855547005335
Brand
NeuroPace® Depth Lead Kit
Company
Neuropace, Inc.
Model
DL-330-10-K
Device description
The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Published
2020-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFNImplanted brain stimulator for epilepsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFNImplanted Brain Stimulator For EpilepsyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100026000
P100026040
P100026069

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100026000NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026040NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026069NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855547005335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855547005335008555470053358555470053350855547005335

GMDN Terms#

Term, Definition table
TermDefinition
Brain-responsive electrical stimulation systemAn assembly of devices designed to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to the detection of abnormal electrical events in the brain for the treatment of neurological disorders (e.g., epilepsy). It consists of a sterile, battery-powered sensing device/stimulator implanted below the scalp; one or more leads, which may be placed on the cortical surface or deep in the brain, and which transmit monitoring data, electrocorticograms and stimulation pulses; telemetric control units for programming the stimulator and/or receiving functional data; and software run on a computing device for analysis and reporting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)726-3876customerservice@neuropace.com

Regulatory Flags#

DUNS number
123369238
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855547005205Burr Hole Cover81102016-08-23
00855547005427NeuroPace® Remote Monitor Kit51072023-11-14
00855547005434NeuroPace® Remote Monitor Kit51072023-11-14
00855547005281RNS® Tablet Kit50012018-01-15
00855547005007NeuroPace® Patient Data Management System (PDMS)Model 43402015-07-22
00855547005366RNS® Neurostimulator KitRNS-320-K2020-03-10
00855547005410Explant KitEX-01-K2022-02-22
00855547005137MagnetM-012014-09-24
00855547005403Remote Monitor Phone Accessories51042020-09-14
00855547005250NeuroPace® Remote Monitor Kit51012018-05-18
00855547005113WandW-022014-09-24
00855547005120RNS® Neurostimulator KitRNS-300M-K2017-12-18
00855547005267RNS® Neurostimulator KitRNS-320-K2018-05-18
00855547005373Ferrule KitF-01-K2020-03-16
00855547005380Craniectomy Template KitCT-01-K2020-03-16
00855547005397Connector Cover KitCC-01-K2020-03-16
00855547005298NeuroPace® Depth Lead KitDL-344-10-K2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitCL-335-10-K2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitCL-325-10-K2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitCL-315-10-K2020-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855547005427NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2023-11-14
00855547005434NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2023-11-14
00855547005410Explant KitNeuropace, Inc.PFN2022-02-22
00855547005403Remote Monitor Phone AccessoriesNeuropace, Inc.PFN2020-09-14
00855547005373Ferrule KitNeuropace, Inc.PFN2020-03-16
00855547005380Craniectomy Template KitNeuropace, Inc.PFN2020-03-16
00855547005397Connector Cover KitNeuropace, Inc.PFN2020-03-16
00855547005298NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005342NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005359NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005366RNS® Neurostimulator KitNeuropace, Inc.PFN2020-03-10
00855547005250NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2018-05-18
00855547005243NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2018-05-18
00855547005267RNS® Neurostimulator KitNeuropace, Inc.PFN2018-05-18
00855547005281RNS® Tablet KitNeuropace, Inc.PFN2018-01-15
00855547005274RNS® Tablet KitNeuropace, Inc.PFN2018-01-15
00855547005120RNS® Neurostimulator KitNeuropace, Inc.PFN2017-12-18
00855547005007NeuroPace® Patient Data Management System (PDMS)Neuropace, Inc.PFN2015-07-22
00855547005083NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2014-09-24
00855547005090NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2014-09-24
00855547005106NeuroPace® Programmer KitNeuropace, Inc.PFN2014-09-24
00855547005014NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005021NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005038NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005045NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005052NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2014-09-24
00855547005069NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2014-09-24