Duns Number:796779283
Device Description: Easy Glide 10cc Luer Lock Syringe
Catalog Number
-
Brand Name
Easy Glide 10cc Luer Lock Syringe
Version/Model Number
671020
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
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
edef769c-848c-40ee-9403-fa72a7ef680d
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
June 26, 2018
Package DI Number
B2086710203
Quantity per Package
10
Contains DI Package
B2086710201
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |