Duns Number:927071162
Device Description: PSF2: Laparoscopic Smoke Evacuation, Passive type, Filter and Fluid Trap - (1 pc per pack PSF2: Laparoscopic Smoke Evacuation, Passive type, Filter and Fluid Trap - (1 pc per pack/ 10 pcs per box)
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
PSF2
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
42697860-70b1-4bd6-a86a-e6a855f46777
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
10817325023761
Quantity per Package
10
Contains DI Package
00817325023764
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |