Duns Number:531856466
Catalog Number
STR-000084-00
Brand Name
NeuroSmart / NeuroNav LeadConfirm P Adaptor
Version/Model Number
NeuroSmart / NeuroNav LeadConfirm P Adaptor
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
K191739,K191739
Product Code
GZL
Product Code Name
Electrode, Depth
Public Device Record Key
6ade7d42-5409-452e-8430-3091befcb428
Public Version Date
June 15, 2022
Public Version Number
1
DI Record Publish Date
June 07, 2022
Package DI Number
17290114063958
Quantity per Package
10
Contains DI Package
07290114063951
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 112 |