Duns Number:021063219
Device Description: MEB-9400 Neuropack S1 Laptop system; performs Evoked potentials, Nerve Conduction and Elec MEB-9400 Neuropack S1 Laptop system; performs Evoked potentials, Nerve Conduction and Electromyography studies
Catalog Number
MEB-9400A-DT
Brand Name
Neuropack
Version/Model Number
MEB-9400A-DT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
IKN
Product Code Name
Electromyograph, diagnostic
Public Device Record Key
9d67fcfa-7ef7-4a26-95d0-e984d8345dc9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 393 |