Axonics

Primary DI
10810005340219
Brand
Axonics
Company
AXONICS MODULATION TECHNOLOGIES, INC.
Model
9003
Catalog number
9003
Device description
Stimulation Ground Cables
Published
2019-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10810005340219PrimaryGS10
00810005340212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000534021910810005340219
00810005340212008100053402128100053402120810005340212

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-use, sterileA sterile dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached cables. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079562449
Device count
6
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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