AccessGUDID - DEVICE: Axonics (10810005340189)

GUDID

Device Identifier (DI) Information

Brand Name: Axonics
Version or Model: 9001-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9001-S
Company Name: AXONICS MODULATION TECHNOLOGIES, INC.

Primary DI Number: 10810005340189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 079562449 *Terms of Use

Device Description: Foramen Needle - Short

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?
63345	Electrical impedance navigation spinal needle	A sharp bevel-edged, hollow tubular metal instrument designed to be used: 1) as a bipolar electrode for real-time bioimpedance-based prediction of the needle tip location; and 2) for lumbar puncture/intrathecal injection. The needle and an included insulated stylet are intended to function as a bipolar electrode whereby tissue at the tip bridges the circuit; electrical signals and subsequent impedance values are interpreted by a navigational unit (not included) to identify tip location, and to confirm contact with cerebrospinal fluid (CSF). 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 [?]
Premarket Submission Number Not Available/Not Released

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: 7e4124f1-402a-47fc-9410-d3c6f2278dcf
Public Version Date: December 18, 2024
Public Version Number: 3
DI Record Publish Date: September 23, 2019