Duns Number:807404611
Catalog Number
CP-08101
Brand Name
CP-CABLE
Version/Model Number
CP-08101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K022075,K022075
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
481d1c8c-be6b-4dfe-8da4-900ce72a09bf
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
July 26, 2016
Package DI Number
20790986004720
Quantity per Package
5
Contains DI Package
10790986004723
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 461 |