Duns Number:123369238
Device Description: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Cas The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case and 1 Ethernet (Network) Cable.
Catalog Number
-
Brand Name
NeuroPace® Remote Monitor Kit
Version/Model Number
DTR-300-E-K
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P100026,P100026,P100026,P100026
Product Code
PFN
Product Code Name
Implanted brain stimulator for epilepsy
Public Device Record Key
6830e234-f16d-4ef0-967a-81f9c1530d04
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 33 |