AccessGUDID - DEVICE: NeuroPace® Remote Monitor Kit (00855547005090)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroPace® Remote Monitor Kit
Version or Model: DTR-300-E-K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neuropace, Inc.

Primary DI Number: 00855547005090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123369238 *Terms of Use

Device Description: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case and 1 Ethernet (Network) Cable.

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?
61947	Brain-responsive electrical stimulation system	An assembly of devices designed to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to the detection of abnormal electrical events in the brain for the treatment of neurological disorders (e.g., epilepsy). It consists of a sterile, battery-powered sensing device/stimulator implanted below the scalp; one or more leads, which may be placed on the cortical surface or deep in the brain, and which transmit monitoring data, electrocorticograms and stimulation pulses; telemetric control units for programming the stimulator and/or receiving functional data; and software run on a computing device for analysis and reporting.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PFN	Implanted brain stimulator for epilepsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100026	000
P100026	011

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: 6830e234-f16d-4ef0-967a-81f9c1530d04
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014