Duns Number:595138793
Device Description: IN-LINE INJECTATE SENSOR CABLE with cable length 96". The cable consists of 3 inner cables IN-LINE INJECTATE SENSOR CABLE with cable length 96". The cable consists of 3 inner cables and a 4-pin connector.
Catalog Number
684062
Brand Name
IN-LINE INJECTATE SENSOR CABLE-SP4045
Version/Model Number
684062
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
-
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
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
e3743f51-0ced-46df-8ec0-3c926b8a314e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2016
Package DI Number
50886333640626
Quantity per Package
1
Contains DI Package
00886333640621
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Zip bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |