FDA.reportPublic FDA data

Senza

Primary DI
00813426020688
Brand
Senza
Company
NEVRO CORP.
Model
ACCK4320
Catalog number
ACCK4320
Device description
Magnet Kit
Published
2021-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130022000NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEMNevro Corporation2015-05-08LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813426020688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813426020688008134260206888134260206880813426020688

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
6502510005info@nevro.com

Regulatory Flags#

DUNS number
926599155
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813426020671SenzaACCK4310ACCK43102021-03-24
00813426020626OmniaCHPS2500CHPS25002019-11-11
00813426020169Senza® PTTK1000PTTK10002015-05-21
00813426020879Nevro®MADP2008-25B2025-02-28
00813426020886Nevro®SADP2008-25B2025-02-28
00813426020091Nevro®SADP2008-25BSADP2008-25B2015-05-21
00813426020107Nevro® MADP2008-25BMADP2008-25B2015-05-21
00813426020565OmniaCHGR2500CHGR25002019-11-11
00813426020121Senza® CHGR1000CHGR10002015-05-21
00813426021227SenzaNIPG3000UNIPG3000U2025-11-07
00813426020787Nevro® ACCK8012-50PACCK8012-50P2022-04-11
00813426020794Nevro® ACCK8012-70PACCK8012-70P2022-04-11
00813426020800Nevro® ACCK8012-90PACCK8012-90P2022-04-11
00813426020725SenzaLEAD1058-50BPLEAD1058-50BP2021-04-30
00813426020756SenzaLEAD1058-90BPLEAD1058-90BP2021-04-30
00813426020763SenzaLEAD1058-70BPLEAD1058-70BP2021-04-29
00813426020824Nevro®LEAD2008-25B2025-02-28
00813426020831Nevro®LEAD2008-35B2025-02-28
00813426020848Nevro®LEAD2008-60B2025-02-28
00813426020077Nevro®LEAD2008-25BLEAD2008-25B2015-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729970606Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-01-16
08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935124NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935179NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935186NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729937395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729931492NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-05-03
08714729763352Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-02-23
08714729789697Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729789703Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729767534Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767541Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767558Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779957NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779964NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789567Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789581Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797807Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797814Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14