AccessGUDID - DEVICE: NeuroPace® Cortical Strip Lead Kit (00855547005052)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroPace® Cortical Strip Lead Kit
Version or Model: CL-335-10-K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neuropace, Inc.

Primary DI Number: 00855547005052
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123369238 *Terms of Use

Device Description: The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
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	040
P100026	069

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
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 35 Centimeter
Device Size Text, specify: 4 electrodes with 10 mm spacing

Device Record Status

Public Device Record Key: b5350d51-b38f-44e8-8bf7-26c4352fed26
Public Version Date: March 04, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2014