Duns Number:013112308
Device Description: HYPODERMIC SAFETY NEEDLE WITH 5CC SYRINGE LUER LOCK 21 X 1.EA.
Catalog Number
SYFTY521
Brand Name
Rospital Productos Medicos
Version/Model Number
SYFTY521
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
d0dcf0bd-746b-41e1-b3c1-11e40712c2ad
Public Version Date
July 14, 2020
Public Version Number
1
DI Record Publish Date
July 06, 2020
Package DI Number
10812460027162
Quantity per Package
100
Contains DI Package
00812460027165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER BOX
| 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 |