Duns Number:006013346
Device Description: 1cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 10ct
Catalog Number
-
Brand Name
Comfort Assist Insulin Syringe
Version/Model Number
103008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 17, 2017
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062702,K062702
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
7236bade-36fe-46ef-aaa5-44e4b07aaa8f
Public Version Date
August 05, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-