Duns Number:047063695
Device Description: Veress Needle 150mm w/Straight Hub
Catalog Number
OS-VN-150S
Brand Name
Veress Needle 150mm w/Straight Hub
Version/Model Number
OS-VN-150S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
a6e6ec48-6a6d-4de1-a763-b0654957c5d7
Public Version Date
August 17, 2021
Public Version Number
4
DI Record Publish Date
November 15, 2016
Package DI Number
B354OSVN150S10
Quantity per Package
10
Contains DI Package
B354OSVN150S0
Package Discontinue Date
November 15, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 271 |