Duns Number:711789789
Device Description: This model includes one of sheath section and six of needle sections. The sheath section i This model includes one of sheath section and six of needle sections. The sheath section is reusable and requires autoclave sterilization prior to use. The needle section is single-use and packaged as sterile. Please refer to the instruction manual for details.
Catalog Number
-
Brand Name
ASPIRATION NEEDLE
Version/Model Number
NA-1C-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 18, 2022
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"
Yes
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
GDM
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, REUSABLE
Public Device Record Key
8d6bd314-a1e9-4963-8664-9f15fb7cb806
Public Version Date
August 19, 2022
Public Version Number
4
DI Record Publish Date
September 21, 2018
Package DI Number
14953170035231
Quantity per Package
6
Contains DI Package
04953170035234
Package Discontinue Date
August 18, 2022
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 | 117 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
| U | Unclassified | 52 |