Duns Number:239403863
Device Description: The Aspiration Needle is for aspiration of fluids from cysts & abdominal organs during lap The Aspiration Needle is for aspiration of fluids from cysts & abdominal organs during laparoscopic procedures.
Catalog Number
PS3895
Brand Name
Aspiration Needle
Version/Model Number
PS3895
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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
b62b97de-d528-4506-90f1-d7daac87184d
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
35051223007419
Quantity per Package
10
Contains DI Package
05051223007418
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 |