Duns Number:021842273
Device Description: 6-Pin DIN Subject Cables (8 ft / 2.4 m Length)
Catalog Number
SC6PIN8
Brand Name
BIA Subject Cables
Version/Model Number
6-Pin Subject Cables (8 ft)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
af7c8c52-e208-4454-a28f-968060c50268
Public Version Date
May 25, 2018
Public Version Number
1
DI Record Publish Date
April 24, 2018
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. | 14 |