Duns Number:961027315
Device Description: SYRINGE NEEDLE 10CC 21GX1.5 LL HYPDRMC
Catalog Number
SN0102115
Brand Name
CARDINAL HEALTH
Version/Model Number
SN0102115
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
a2c4af15-38a3-4c73-a7b0-1404b97ac9e1
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
September 08, 2016
Package DI Number
20885380119511
Quantity per Package
100
Contains DI Package
10885380119514
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |