Duns Number:071595540
Device Description: AirSeal 8mm Cannula Cap and Obtuator with Bladeless Optical Tip, Standard Length
Catalog Number
iAS8-dV
Brand Name
AirSeal
Version/Model Number
iAS8-dV
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
K211104,K211104,K211104
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
17faed25-ac26-4170-b855-f168dae7429f
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 22, 2021
Package DI Number
20845854051396
Quantity per Package
1
Contains DI Package
10845854051399
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 | 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 |