Duns Number:787855907
Device Description: Laparoscopic Plume Filtration Device
Catalog Number
PP010CS
Brand Name
PlumePort
Version/Model Number
ActiV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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"
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
-
Product Code
NKC
Product Code Name
Tubing/Tubing With Filter, Insufflation, Laparoscopic
Public Device Record Key
641a39f8-0680-4cad-a9e6-6a69a6ea5240
Public Version Date
April 22, 2022
Public Version Number
3
DI Record Publish Date
January 05, 2017
Package DI Number
10815198012028
Quantity per Package
10
Contains DI Package
00815198012021
Package Discontinue Date
April 21, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 104 |