Duns Number:053469565
Device Description: 19 Gauge x 8" Aspirating Needle, W/ Sharp Cannula. Sterile & Non-Pyrogenic, Individually B 19 Gauge x 8" Aspirating Needle, W/ Sharp Cannula. Sterile & Non-Pyrogenic, Individually Blister Packed, Box of 100
Catalog Number
32-23
Brand Name
Aspirating Needle
Version/Model Number
32-23
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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
a5591186-6247-48a2-b63d-04cc20658169
Public Version Date
August 09, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
B21232232
Quantity per Package
100
Contains DI Package
B21232231
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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. | 15 |