Duns Number:058614483
Device Description: Laparoscopic Smoke Evacuation System Active and Passive
Catalog Number
-
Brand Name
Valleylab
Version/Model Number
SEL7010
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"
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
71df30df-227d-403d-92fc-8ef24defedc9
Public Version Date
February 09, 2022
Public Version Number
2
DI Record Publish Date
September 03, 2020
Package DI Number
20884521740867
Quantity per Package
10
Contains DI Package
10884521740860
Package Discontinue Date
-
Package Status
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |