FDA.reportPublic FDA data

Nevro®

Primary DI
00813426020800
Brand
Nevro®
Company
NEVRO CORP.
Model
ACCK8012-90P
Catalog number
ACCK8012-90P
Device description
Stylet Kit, 90cm Length, w/ .016 stylet
Published
2022-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00813426020800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813426020800008134260208008134260208000813426020800

GMDN Terms#

Term, Definition table
TermDefinition
Central nervous system electrical stimulation system lead styletA wire intended to be percutaneously inserted into the brain and/or epidural space to aid in the percutaneous placement of an implantable central nervous system (CNS) electrical stimulation system lead. It is manipulated proximally with the distal working end typically comprised of thin metal wire. This is a single-use device.

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
Expiration 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
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
00813426021098SenzaTLEAD1058-50B2025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08714729797821Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797838NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729821540NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767640Precision ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09
08714729772699NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09