Duns Number:658122465
Catalog Number
-
Brand Name
Veress Needle
Version/Model Number
FVN115000
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
K111441,K111441,K111441
Product Code
FHO
Product Code Name
Pneumoperitoneum Needle
Public Device Record Key
0231f24d-ce51-44bb-80b8-6ad0740640b9
Public Version Date
July 14, 2020
Public Version Number
4
DI Record Publish Date
June 19, 2017
Package DI Number
24714127862020
Quantity per Package
100
Contains DI Package
14714127862023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
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. | 67 |