Duns Number:239403863
Device Description: The Ultimate Veress Needle is used to establish a pneumoperitoneum prior to abdominal lapa The Ultimate Veress Needle is used to establish a pneumoperitoneum prior to abdominal laparoscopic procedures.
Catalog Number
PS3760ULT
Brand Name
Ultimate Veress Needle
Version/Model Number
PS3760ULT
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
-
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
f306e5ab-a9fc-4945-a477-6ea34aa56df7
Public Version Date
June 29, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
55051223007680
Quantity per Package
100
Contains DI Package
35051223007686
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |