Duns Number:180572216
Device Description: Safety Needle, 19G X 1 1/2
Catalog Number
27438
Brand Name
Exel SecureTouch Safety Needle
Version/Model Number
27438
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
66734612-eda7-46e0-a364-914d90a71961
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
20020221274381
Quantity per Package
10
Contains DI Package
10020221274384
Package Discontinue Date
-
Package Status
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 82 |