AccessGUDID - DEVICE: Wand (00855547005113)

GUDID

Device Identifier (DI) Information

Brand Name: Wand
Version or Model: W-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neuropace, Inc.

Primary DI Number: 00855547005113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123369238 *Terms of Use

Device Description: The Wand package contains 1 Wand.

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:	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	043
P100026	066

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
Storage Environment Temperature: between 0 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4348ca0a-4f3b-4b4f-900f-29f85b100fec
Public Version Date: September 21, 2020
Public Version Number: 5
DI Record Publish Date: September 24, 2014

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: Yes
DM DI Number: 00855547005236
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)726-3876
Email: customerservice@neuropace.com

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