NeuroPace® Cortical Strip Lead Kit

GUDID 00855547005076

The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.

Neuropace, Inc.

Brain-responsive electrical stimulation system
Primary Device ID00855547005076
NIH Device Record Key1abf42d2-521c-48cc-8bd9-b7402bbc2c0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroPace® Cortical Strip Lead Kit
Version Model NumberCL-315-10-K
Company DUNS123369238
Company NameNeuropace, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)726-3876
Emailcustomerservice@neuropace.com

Device Dimensions

Length15 Centimeter
Length15 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855547005076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PFNImplanted brain stimulator for epilepsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-04
Device Publish Date2014-09-24

On-Brand Devices [NeuroPace® Cortical Strip Lead Kit]

00855547005076The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Sutur
00855547005069The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Sutur
00855547005052The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Sutur
00855547005328The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Sutur
00855547005311The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Sutur
00855547005304The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Sutur

Trademark Results [NeuroPace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEUROPACE
NEUROPACE
85420301 not registered Dead/Abandoned
NeuroPace, Inc.
2011-09-12
NEUROPACE
NEUROPACE
78872716 3213127 Live/Registered
NeuroPace, Inc.
2006-04-28
NEUROPACE
NEUROPACE
78872712 3213126 Live/Registered
NeuroPace, Inc.
2006-04-28
NEUROPACE
NEUROPACE
76360887 not registered Dead/Abandoned
NeuroPace, Inc.
2002-01-22
NEUROPACE
NEUROPACE
75401605 2269819 Dead/Cancelled
NEUROPACE, INC.
1997-12-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.