Duns Number:066087031
Device Description: Safety needle 18G, 1 1/2"
Catalog Number
NS1815A3
Brand Name
Endure
Version/Model Number
NS1815A3-0820
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
2cee566e-1970-49da-b3f5-5c020e475c36
Public Version Date
April 14, 2021
Public Version Number
1
DI Record Publish Date
April 06, 2021
Package DI Number
00840118604222
Quantity per Package
100
Contains DI Package
00840118604215
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |