Duns Number:078511333
Device Description: Electromyography Lead -- 2 Channel MEP Adaptor
Catalog Number
4695G
Brand Name
Personal Medical Corp
Version/Model Number
2 Channel MEP Adaptor
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2025
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
57292c41-4504-46b9-b685-62600ddc9014
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 06, 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. | 12 |