AccessGUDID - DEVICE: Axonics (10810005340523)

GUDID

Device Identifier (DI) Information

Brand Name: Axonics
Version or Model: FFG-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FFG-01
Company Name: AXONICS MODULATION TECHNOLOGIES, INC.

Primary DI Number: 10810005340523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079562449 *Terms of Use

Device Description: Axonics Foramen Finder

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZW	Stimulator, Electrical, Implantable, For Incontinence
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180046	079
P190006	079

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2430a5ac-dc4d-4b52-a6a5-2f271488e80d
Public Version Date: February 13, 2025
Public Version Number: 1
DI Record Publish Date: February 05, 2025