NeuroPace® Remote Monitor Kit

GUDID 00855547005182

The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case and 1 Ethernet (Network) Cable.

Neuropace, Inc.

Brain-responsive electrical stimulation system
Primary Device ID00855547005182
NIH Device Record Key6830e234-f16d-4ef0-967a-81f9c1530d04
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroPace® Remote Monitor Kit
Version Model NumberDTR-300-E-K
Company DUNS123369238
Company NameNeuropace, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS100855547005090 [Primary]
GS100855547005182 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PFNImplanted brain stimulator for epilepsy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

On-Brand Devices [NeuroPace® Remote Monitor Kit]

00855547005243The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1
00855547005182The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case an
00855547005199The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1
00855547005434The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Cas

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

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