NeuroPace® Depth Lead Kit

GUDID 00855547005014

The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.

Neuropace, Inc.

Brain-responsive electrical stimulation system
Primary Device ID00855547005014
NIH Device Record Key3cd84744-1fb2-46af-a0a3-4200b8cb06b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroPace® Depth Lead Kit
Version Model NumberDL-344-10-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

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855547005014 [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® Depth Lead Kit]

00855547005045The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop
00855547005038The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop
00855547005021The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop
00855547005014The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop
00855547005359The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop
00855547005342The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop
00855547005335The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop
00855547005298The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop

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.