FDA.reportPublic FDA data

Axonics

Primary DI
10810005340141
Brand
Axonics
Company
AXONICS MODULATION TECHNOLOGIES, INC.
Model
1201
Catalog number
1201
Device description
Tined Lead Kit
Published
2019-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZWStimulator, Electrical, Implantable, For Incontinence
QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3
QONImplanted Electrical Device Intended For Treatment Of Fecal IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190006000Axonics Sacral Neuromodulation SystemBoston Scientific Corporation2019-09-06QON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810005340141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081000534014110810005340141

GMDN Terms#

Term, Definition table
TermDefinition
Sacral plexus implantable incontinence-control electrical stimulation system electrodeAn implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence. It is implanted on the sacral plexus or in its vicinity (e.g., anal sphincter, bladder wall, pelvic floor) to make an electrical connection between an implantable electrical stimulation system pulse generator and the sacral plexus area.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (877) 929-6642customersupport@axonics.com

Regulatory Flags#

DUNS number
079562449
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810005340424Axonics9108-R2020-11-03
10810005340431Axonics9108-E2020-11-03
10810005340233Axonics900590052019-09-23
10810005340264Axonics9008-R9008-R2019-09-23
10810005340271Axonics9008-E9008-E2019-09-23
10810005340011Axonics140114012019-09-23
10810005340370Axonics140114012019-09-23
10810005340387Axonics140114012019-09-23
10810005340479Axonics510151012023-09-08
10810005340455Axonics410141012022-03-11
10810005340066Axonics110111012019-09-23
10810005340523AxonicsFFG-01FFG-012025-02-05
10810005340509Bulkamid500502023-09-12
10810005340578Axonics900990092024-07-29
10810005340493Bulkamid600302023-08-30
10810005340486Axonics901590152022-06-14
10810005340035Axonics250125012019-09-23
10810005340059Axonics160116012019-09-23
10810005340080Axonics180118012019-09-23
10810005340103Axonics230123012019-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150005918NAMEDTRONIC, INC.QON2026-03-27
00199150005918NAMEDTRONIC, INC.EZW2026-03-27
00199150005925NAMEDTRONIC, INC.QON2026-03-27
00199150005925NAMEDTRONIC, INC.EZW2026-03-27
10810005340523AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2025-02-05
10810005340578AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2024-07-29
00763000596835InterStim™SureScan™MEDTRONIC, INC.QON2024-01-22
00763000596873InterStim™SureScan™MEDTRONIC, INC.EZW2024-01-22
00763000612832N/AMEDTRONIC, INC.QON2024-01-19
00763000612832N/AMEDTRONIC, INC.EZW2024-01-19
00763000596798InterStim™SureScan™MEDTRONIC, INC.QON2023-12-15
00763000596910InterStim™SureScan™MEDTRONIC, INC.QON2023-12-15
10810005340479AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2023-09-08
00763000825997NAMEDTRONIC, INC.EZW2023-04-07
00763000596996InterStim™SureScan™MEDTRONIC, INC.QON2023-01-23
00763000596958InterStim™SureScan™MEDTRONIC, INC.EZW2023-01-01
10810005340486AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2022-06-14
00763000596736InterStim™ Micro SureScan™ MRIMEDTRONIC, INC.EZW2022-06-05
10810005340455AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2022-03-11
00763000484668InterStim™ XMEDTRONIC, INC.EZW2022-03-04
00763000517182NAMEDTRONIC, INC.QON2022-03-04
00763000517199NAMEDTRONIC, INC.QON2022-03-04
00763000582470NAMEDTRONIC, INC.QON2022-03-04
00763000582487NAMEDTRONIC, INC.EZW2022-03-04
00763000449711INTERSTIM® IIMEDTRONIC, INC.EZW2021-05-30
00763000433864N/AMEDTRONIC, INC.QON2021-05-21
00763000433871N/AMEDTRONIC, INC.QON2021-05-21
00763000343286NAMEDTRONIC, INC.QON2021-02-15
00763000295523InterStim™MEDTRONIC, INC.QON2021-01-25
00763000295547InterStim™MEDTRONIC, INC.QON2021-01-25