FDA UDI
In Commercial Distribution
🇺🇸 United States
Axonics
DI: 10810005340486
·
Model: 9015
·
AXONICS MODULATION TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Axonics
- Primary DI
- 10810005340486
- Version / Model
- 9015
- Catalog Number
- 9015
- Company Name
- AXONICS MODULATION TECHNOLOGIES, INC.
- Labeler DUNS
- 079562449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-06-14
- Public Version
- 1
- Public Version Date
- 2022-06-22
- Public Version Status
- New
- Public Device Record Key
- 1fba4c72-c0e0-4e7b-aa0b-7a2a4a3bb32c
Device Description
Curved Stylet
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47143 | Electrical-only medical device connection cable, single-use | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810005340486 | GS1 | ||||
| Unit of Use | 00810005340489 | GS1 |
Customer Contacts
- Phone
- +1 (877) 929-6642
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180046 | 000 |