Duns Number:006013346
Device Description: .5cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
Catalog Number
-
Brand Name
GoodSense Comfort Assist Insulin Syringes
Version/Model Number
053008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2018
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,K062702
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
b900b8c5-323b-4625-b8e4-ab9da5703bbd
Public Version Date
July 11, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10370030128751
Quantity per Package
30
Contains DI Package
00370030128754
Package Discontinue Date
July 08, 2018
Package Status
Not in Commercial Distribution
Package Type
Shipper