RNS® Tablet Kit

GUDID 00855547005274

The RNS® Tablet package contains 1 RNS® Tablet, 1 Stylus, 1 AC Adapter and 1 Carrying Case.

Neuropace, Inc.

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Primary Device ID00855547005274
NIH Device Record Key7c5941e6-e1d9-4bea-966b-27885a069491
Commercial Distribution StatusIn Commercial Distribution
Brand NameRNS® Tablet Kit
Version Model Number5001
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100855547005274 [Direct Marking]
GS100855547005281 [Primary]

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 Date2018-01-15

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00855547005434 - NeuroPace® Remote Monitor Kit2023-11-22 The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.
00855547005410 - Explant Kit2022-03-02 The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
00855547005403 - Remote Monitor Phone Accessories2020-09-22 The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.
00855547005373 - Ferrule Kit2020-03-24 The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
00855547005380 - Craniectomy Template Kit2020-03-24 The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
00855547005397 - Connector Cover Kit2020-03-24 The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
00855547005298 - NeuroPace® Depth Lead Kit2020-03-23 The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw
00855547005304 - NeuroPace® Cortical Strip Lead Kit2020-03-23 The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool S

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