FDA.reportPublic FDA data

Axonics

Primary DI
10810005340387
Brand
Axonics
Company
AXONICS MODULATION TECHNOLOGIES, INC.
Model
1401
Catalog number
1401
Device description
Charging Device
Published
2019-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10810005340387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081000534038710810005340387

GMDN Terms#

Term, Definition table
TermDefinition
Implant battery chargerAn electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079562449
Device count
1
Serial number
true
Manufacturing 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
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
10810005340127Axonics190119012019-09-23

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.EZW2026-03-27
00199150005925NAMEDTRONIC, INC.QON2026-03-27
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
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
20763000343273InterStim™MEDTRONIC, INC.EZW2021-01-14