Duns Number:071595540
Device Description: AIRSEAL 12MM ACCESS PORT AND OBTURATOR WITH BLADELESS OPTICAL TIP, 100MM LENGTH
Catalog Number
IAS12-100
Brand Name
AIRSEAL
Version/Model Number
IAS12-100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 22, 2018
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
6e1a2c68-73c9-4408-968b-f4ea3f2f6310
Public Version Date
January 09, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20851885004171
Quantity per Package
6
Contains DI Package
10851885004174
Package Discontinue Date
February 22, 2018
Package Status
Not 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 |