Duns Number:879187821
Device Description: Safety Hypodermic Needle with Syringe, Low Dead Space, 3ml, 25G x 1"
Catalog Number
SHN25G101-S3ML-LDS
Brand Name
RELI®
Version/Model Number
SHN25G101-S3ML-LDS
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
4e6b3d10-4977-42b2-97ab-ed4beae98561
Public Version Date
February 09, 2022
Public Version Number
1
DI Record Publish Date
February 01, 2022
Package DI Number
10386120011711
Quantity per Package
100
Contains DI Package
00386120011714
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |