Remote Monitor Phone Accessories

GUDID 00855547005403

The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.

Neuropace, Inc.

Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system
Primary Device ID00855547005403
NIH Device Record Keyfc28124f-020b-46fb-98cd-d88271000455
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemote Monitor Phone Accessories
Version Model Number5104
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 Usefalse
Lot Batchtrue
Serial Numberfalse
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

Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com
Phone866-726-3876
Emailcustomerservice@neuropace.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855547005403 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-22
Device Publish Date2020-09-14

Devices Manufactured by Neuropace, Inc.

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 Accessories2020-09-22The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.
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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