AccessGUDID - DEVICE: Axonics (10810005340028)

GUDID

Device Identifier (DI) Information

Brand Name: Axonics
Version or Model: 1501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1501
Company Name: AXONICS MODULATION TECHNOLOGIES, INC.

Primary DI Number: 10810005340028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079562449 *Terms of Use

Device Description: Clinician Programmer

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:	No
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?
44073	Implantable incontinence-control electrical stimulation system programmer, line-powered	A line-powered, external device intended to change, noninvasively, one or more of the operating parameters (the programs) of an implanted incontinence-control electrical stimulation system pulse generator. It is designed to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC drives the electronics of the wand to communicate with the implanted stimulation system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZW	Stimulator, Electrical, Implantable, For Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190006	000

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: eb85837c-a7e8-4871-bb9c-47695cf8a881
Public Version Date: October 01, 2019
Public Version Number: 1
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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