Duns Number:896421240
Device Description: Macro Stimulator
Catalog Number
9031E0752
Brand Name
Leadpoint
Version/Model Number
9031E0752
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
K140680
Product Code
GZL
Product Code Name
Electrode, Depth
Public Device Record Key
712d363e-5bde-4275-baa4-c67be9a0b79a
Public Version Date
March 20, 2019
Public Version Number
1
DI Record Publish Date
March 12, 2019
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 154 |