Duns Number:316661214
Device Description: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
Catalog Number
145096V2
Brand Name
Nit-Occlud PDA
Version/Model Number
145096V2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
For Single-Use
Yes
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
P120009,P120009
Product Code
MAE
Product Code Name
Occluder, Patent Ductus, Arteriosus
Public Device Record Key
d4078ab1-515f-404f-8994-52deaa6ed55b
Public Version Date
April 08, 2022
Public Version Number
6
DI Record Publish Date
August 06, 2014
Package DI Number
4042301160027
Quantity per Package
10
Contains DI Package
04042301160010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 5 |