Duns Number:308951313
Device Description: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephros Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy, PTC) preceding introduction of guidewires.
Catalog Number
N12021150
Brand Name
Access Needle
Version/Model Number
N12021150
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"
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
GCB
Product Code Name
Needle, Catheter
Public Device Record Key
f9f41d22-69c2-49a4-a68f-6ce382df91d2
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
August 05, 2019
Package DI Number
05711055001908
Quantity per Package
20
Contains DI Package
15711055001905
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |