Duns Number:938289980
Device Description: A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid fro A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device.
Catalog Number
201005-000
Brand Name
16ga Air Aspirator Needle w/Blue Cap
Version/Model Number
201005-000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K801393,K801393,K801393,K801393,K801393
Product Code
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
7cd062a3-0dfc-471a-be1b-a3590976aea4
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
B0662010050006
Quantity per Package
100
Contains DI Package
B0662010050000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |