Duns Number:013112308
Device Description: HYPODERMIC SAFETY NEEDLE WITH 10CC SYRINGE LUER LOCK 21G X 1 1/2",EA.
Catalog Number
SYFTY10215
Brand Name
Rospital Productos Medicos
Version/Model Number
SYFTY10215
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
K190183,K190183,K190183
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
f8658c6f-5c76-4ec5-86a9-48279508bb1f
Public Version Date
July 14, 2020
Public Version Number
1
DI Record Publish Date
July 06, 2020
Package DI Number
10812460027186
Quantity per Package
100
Contains DI Package
00812460027189
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |