FDA UDI
In Commercial Distribution
🇺🇸 United States
Axonics
DI: 10810005340523
·
Model: FFG-01
·
AXONICS MODULATION TECHNOLOGIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Axonics
- Primary DI
- 10810005340523
- Version / Model
- FFG-01
- Catalog Number
- FFG-01
- Company Name
- AXONICS MODULATION TECHNOLOGIES, INC.
- Labeler DUNS
- 079562449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-05
- Public Version
- 1
- Public Version Date
- 2025-02-13
- Public Version Status
- New
- Public Device Record Key
- 2430a5ac-dc4d-4b52-a6a5-2f271488e80d
Device Description
Axonics Foramen Finder
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 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57833 | Medical ruler, single-use | A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810005340523 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180046 | 079 |
| P190006 | 079 |