AccessGUDID - DEVICE: NeuroPace® Patient Data Management System (PDMS) (00855547005007)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroPace® Patient Data Management System (PDMS)
Version or Model: Model 4340
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neuropace, Inc.

Primary DI Number: 00855547005007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123369238 *Terms of Use

Device Description: The NeuroPace® Patient Data Management System (PDMS), part of the NeuroPace® RNS® System, is used to store and provide access to historical RNS® Neurostimulator and patient data. The PDMS can also be used to create and simulate detection settings that can be sent to a user identified NeuroPace® Programmer for use at a later date. PDMS is stand-alone software that is accessible via secure internet connection.

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?
11332	Cannulated surgical drill bit, reusable	A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.	Active	false

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	036
P100026	047
P100026	082
P100026	090

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: e92d4ff7-a081-4bf5-9855-c100ad8b4fff
Public Version Date: November 01, 2022
Public Version Number: 6
DI Record Publish Date: July 22, 2015