Duns Number:071595540
Device Description: AIRSEAL BIFURCATED SMOKE EVAC FILTERED SUBE SET
Catalog Number
SEM-EVAC
Brand Name
AIRSEAL
Version/Model Number
SEM-EVAC
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
HIF
Product Code Name
INSUFFLATOR, LAPAROSCOPIC
Public Device Record Key
6700b7a7-68f5-44c9-b68e-9d2c14a18381
Public Version Date
October 17, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
30851885004017
Quantity per Package
6
Contains DI Package
10851885004013
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 |