Duns Number:054180248
Device Description: 0.5 ML 29GX1/2"
Catalog Number
-
Brand Name
UltraFlo Insulin Syringe
Version/Model Number
225937
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)
Yes
Over the Counter (OTC)
-
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
24b7d764-8eae-4438-a18a-415d2e7d06a5
Public Version Date
January 20, 2020
Public Version Number
2
DI Record Publish Date
June 24, 2019
Package DI Number
B7442259373
Quantity per Package
6
Contains DI Package
B7442259372
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton