Duns Number:021063219
Device Description: Preassembled MEB-9600 on Cart for MEB-9600 Neuropack S3 desktop system, performs Evoked po Preassembled MEB-9600 on Cart for MEB-9600 Neuropack S3 desktop system, performs Evoked potentials, nerve conduction and electromyography studies
Catalog Number
MEB-9600
Brand Name
Neuropack S3
Version/Model Number
NPS3-LT-Cart4-ZA
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
-
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
bdc28ff1-2cbe-4dd6-8da8-5fd94ce281ad
Public Version Date
July 28, 2020
Public Version Number
1
DI Record Publish Date
July 20, 2020
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 |