Duns Number:796779283
Device Description: Easy Glide INSULIN SYRIN 0.3 ML 30GX1/2" 1/2 UNIT MARKING
Catalog Number
-
Brand Name
Easy Glide INSULIN SYRIN 0.3 ML 30GX1/2" 1/2 UNIT MARKING
Version/Model Number
634503
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110421,K110421,K110421,K110421
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
d5105c24-d203-44d1-97ea-ff371aa89979
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
B2086345033
Quantity per Package
6
Contains DI Package
B2086345032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |