Duns Number:827132015
Device Description: XactTrode Patient Cable, 32 Contact with DIN Lead Connector, 6ft
Catalog Number
028903
Brand Name
XactTrode Patient Cable
Version/Model Number
028903
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
K191346
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
2c02b58e-637c-406e-b054-d5c79a1fd5d3
Public Version Date
February 12, 2021
Public Version Number
1
DI Record Publish Date
February 04, 2021
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. | 108 |