Duns Number:796452311
Device Description: TRUNK CABLE, 5LD, PHILIPS, TWIN PIN, 15' AHA, 45°
Catalog Number
25927
Brand Name
TRUNK CABLE, 5LD, PHILIPS, TWIN PIN, 15' AHA, 45°
Version/Model Number
TCB-05JB-15AS-0120
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
K081762
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
c503e6bc-bf17-4462-9b67-9df5b9be9f98
Public Version Date
April 15, 2020
Public Version Number
1
DI Record Publish Date
April 07, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |