AccessGUDID - DEVICE: Axonics (10810005340127)

GUDID

Device Identifier (DI) Information

Brand Name: Axonics
Version or Model: 1901
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1901
Company Name: AXONICS MODULATION TECHNOLOGIES, INC.

Primary DI Number: 10810005340127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079562449 *Terms of Use

Device Description: PNE Lead

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?
63365	Implantable electrical stimulation system intraoperative test lead	A flexible wire intended to be used during open surgical implantation of an electrical stimulation system, and designed to conduct electrical impulses from an external (nonimplantable) pulse generator to the implantable electrode prior to full system implantation to ensure the electrode is positioned correctly, through intraoperative observation of the desired nerve response. This is a single-use device.	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: 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: 44502158-ec98-4d12-b6da-f0856a4cfac3
Public Version Date: December 18, 2024
Public Version Number: 3
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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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