AccessGUDID - DEVICE: Axonics (10810005340059)

GUDID

Device Identifier (DI) Information

Brand Name: Axonics
Version or Model: 1601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1601
Company Name: AXONICS MODULATION TECHNOLOGIES, INC.

Primary DI Number: 10810005340059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079562449 *Terms of Use

Device Description: Trial Stimulator

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?
61392	Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator	A portable, external battery-powered component of a sacral plexus percutaneous incontinence-control electrical stimulation system, intended to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via percutaneous electrodes (not included). It may be self-controlled or controlled by a separate external programmer. It is typically used during a trial period (<30days) to validate the therapy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
EZW	Stimulator, Electrical, Implantable, For 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: No
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: 5b0494e1-6ad7-4572-b6e0-e255715aa5a8
Public Version Date: December 18, 2024
Public Version Number: 2
DI Record Publish Date: September 23, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 (877) 929-6642
Email: customersupport@axonics.com

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