Duns Number:008171162
Device Description: Sterile Safety Syringe
Catalog Number
-
Brand Name
ASSURE® ID Insulin 1cc Safety Syringe
Version/Model Number
210291
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103011,K103011,K103011
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
6e14eff8-fc0e-41a3-9e43-cc55594f2a38
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10015482102910
Quantity per Package
100
Contains DI Package
00015482102913
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 50 |