Duns Number:013112308
Device Description: 1ML INSULIN SYRINGE-U-100 WITH PERMANENTLY ATTACHED NEEDLE 31G X 5/16 IN. Each
Catalog Number
SYINS131
Brand Name
Rospital Productos Medicos
Version/Model Number
SYINS131
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
K110421,K110421,K110421
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
d0258dc4-8f68-4bed-b5ad-4878ab992569
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 2020
Package DI Number
10812460026738
Quantity per Package
100
Contains DI Package
00812460026731
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER CASE
| 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 |