Duns Number:300802068
Catalog Number
-
Brand Name
Reference Electrode Cable (Med4)
Version/Model Number
9001C03
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 18, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080950
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
b9fe2e41-52f1-4903-8cf4-4478abd142df
Public Version Date
February 19, 2021
Public Version Number
8
DI Record Publish Date
September 23, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 86 |