NeuroPace® Remote Monitor Kit
GUDID 00855547005243
The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter and 1 Ethernet (Network) Cable.
Neuropace, Inc.
Brain-responsive electrical stimulation system| Primary Device ID | 00855547005243 |
| NIH Device Record Key | 3c488f17-2635-46c2-a116-1395d556a11c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroPace® Remote Monitor Kit |
| Version Model Number | 5101 |
| Company DUNS | 123369238 |
| Company Name | Neuropace, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855547005243 [Direct Marking] |
| GS1 | 00855547005250 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P100026
FDA Product Code
| PFN | Implanted brain stimulator for epilepsy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-18 |
On-Brand Devices [NeuroPace® Remote Monitor Kit]
| 00855547005243 | The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1 |
| 00855547005182 | The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case an |
| 00855547005199 | The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1 |
| 00855547005434 | The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Cas |
Trademark Results [NeuroPace]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROPACE 85420301 not registered Dead/Abandoned |
NeuroPace, Inc. 2011-09-12 |
 NEUROPACE 78872716 3213127 Live/Registered |
NeuroPace, Inc. 2006-04-28 |
 NEUROPACE 78872712 3213126 Live/Registered |
NeuroPace, Inc. 2006-04-28 |
 NEUROPACE 76360887 not registered Dead/Abandoned |
NeuroPace, Inc. 2002-01-22 |
 NEUROPACE 75401605 2269819 Dead/Cancelled |
NEUROPACE, INC. 1997-12-08 |
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