AccessGUDID - DEVICE: NeuroSphere™ (05415067050311)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroSphere™
Version or Model: 3876
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3876
Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Primary DI Number: 05415067050311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021675699 *Terms of Use

Device Description: Digital Health App

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?
61393	Multiple active implantable device programmer	An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHY	Stimulator, electrical, implanted, for parkinsonian tremor
PMP	Dorsal root ganglion stimulator for pain relief
LGW	Stimulator, spinal-cord, totally implanted for pain relief
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms
PJS	Stimulator, electrical, implanted, for essential tremor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010032	213
P140009	095
P150004	071

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: e76891fd-6f54-4a34-a152-1ea2d74ec860
Public Version Date: January 27, 2025
Public Version Number: 1
DI Record Publish Date: January 17, 2025