Duns Number:006261481
Device Description: CABLE 5433VL VENTRICAL PATIENT 12FT
Catalog Number
-
Brand Name
NA
Version/Model Number
5433VL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2018
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
P820003
Product Code
LWP
Product Code Name
Implantable pulse generator, pacemaker (non-CRT)
Public Device Record Key
679bb811-b88e-4515-a735-37974f77647a
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2014
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 | 102 |
2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
3 | A medical device with high risk that requires premarket approval | 3601 |