FDA.reportPublic FDA data

Magnet

Primary DI
00855547005137
Brand
Magnet
Company
Neuropace, Inc.
Model
M-01
Device description
The Magnet package contains 1 Magnet.
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFNImplanted brain stimulator for epilepsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFNImplanted Brain Stimulator For EpilepsyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100026000
P100026054
P100026082

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100026000NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026054NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026082NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855547005137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855547005137008555470051378555470051370855547005137

GMDN Terms#

Term, Definition table
TermDefinition
Implantable stimulator control magnetA hand-operated, non-sterile, magnetic device designed to be used by a patient to switch an implanted stimulator (e.g., a neurostimulator that can be controlled by a strong external magnetic force) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implanted stimulator and turned as prescribed by the manufacturer to affect the stimulator. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)726-3876customerservice@neuropace.com

Regulatory Flags#

DUNS number
123369238
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855547005205Burr Hole Cover81102016-08-23
00855547005427NeuroPace® Remote Monitor Kit51072023-11-14
00855547005434NeuroPace® Remote Monitor Kit51072023-11-14
00855547005281RNS® Tablet Kit50012018-01-15
00855547005007NeuroPace® Patient Data Management System (PDMS)Model 43402015-07-22
00855547005366RNS® Neurostimulator KitRNS-320-K2020-03-10
00855547005410Explant KitEX-01-K2022-02-22
00855547005403Remote Monitor Phone Accessories51042020-09-14
00855547005250NeuroPace® Remote Monitor Kit51012018-05-18
00855547005113WandW-022014-09-24
00855547005120RNS® Neurostimulator KitRNS-300M-K2017-12-18
00855547005267RNS® Neurostimulator KitRNS-320-K2018-05-18
00855547005373Ferrule KitF-01-K2020-03-16
00855547005380Craniectomy Template KitCT-01-K2020-03-16
00855547005397Connector Cover KitCC-01-K2020-03-16
00855547005298NeuroPace® Depth Lead KitDL-344-10-K2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitCL-335-10-K2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitCL-325-10-K2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitCL-315-10-K2020-03-15
00855547005335NeuroPace® Depth Lead KitDL-330-10-K2020-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855547005427NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2023-11-14
00855547005434NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2023-11-14
00855547005410Explant KitNeuropace, Inc.PFN2022-02-22
00855547005403Remote Monitor Phone AccessoriesNeuropace, Inc.PFN2020-09-14
00855547005373Ferrule KitNeuropace, Inc.PFN2020-03-16
00855547005380Craniectomy Template KitNeuropace, Inc.PFN2020-03-16
00855547005397Connector Cover KitNeuropace, Inc.PFN2020-03-16
00855547005298NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005335NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005342NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005359NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005366RNS® Neurostimulator KitNeuropace, Inc.PFN2020-03-10
00855547005250NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2018-05-18
00855547005243NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2018-05-18
00855547005267RNS® Neurostimulator KitNeuropace, Inc.PFN2018-05-18
00855547005281RNS® Tablet KitNeuropace, Inc.PFN2018-01-15
00855547005274RNS® Tablet KitNeuropace, Inc.PFN2018-01-15
00855547005120RNS® Neurostimulator KitNeuropace, Inc.PFN2017-12-18
00855547005007NeuroPace® Patient Data Management System (PDMS)Neuropace, Inc.PFN2015-07-22
00855547005083NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2014-09-24
00855547005090NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2014-09-24
00855547005106NeuroPace® Programmer KitNeuropace, Inc.PFN2014-09-24
00855547005014NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005021NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005038NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005045NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005052NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2014-09-24