Duns Number:071595540
Device Description: Active Laparoscopic Plume Filtration Device
Catalog Number
0620-030-100
Brand Name
NA
Version/Model Number
0620-030-100
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)
-
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
03cd9cda-ab43-420e-9d71-e61dadd7d8fb
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 2020
Package DI Number
30845854061446
Quantity per Package
10
Contains DI Package
20845854061449
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |