DEVICE: RNS® Neurostimulator Kit (00855547005120)

Device Identifier (DI) Information

RNS® Neurostimulator Kit
RNS-300M-K
In Commercial Distribution

Neuropace, Inc.
00855547005120
GS1

1
123369238 *Terms of Use
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
PFN Implanted brain stimulator for epilepsy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P100026 000
P100026 017
P100026 026
P100026 028
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

7ba9a828-bdb3-4d59-9b78-c1115f3d4819
July 06, 2018
3
December 18, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(866)726-3876
customerservice@neuropace.com
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