Duns Number:848693730
Device Description: LAPAROSCOPIC SMOKE ELIMINATION DEVICE
Catalog Number
9660-XENS
Brand Name
PNEUVIEW XE
Version/Model Number
9660-XENS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2020
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
FCZ
Product Code Name
Tube, Smoke Removal, Endoscopic
Public Device Record Key
6a28dcec-891f-4f8b-9d84-dce295a8d921
Public Version Date
November 06, 2020
Public Version Number
3
DI Record Publish Date
February 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |