Duns Number:081149273
Device Description: Ultra-Care Insulin Syringe 31G 5/16" 1 CC 100 Ct
Catalog Number
-
Brand Name
Ultra-Care Insulin Syringe 31G 5/16" 1 CC 100 Ct
Version/Model Number
240406
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
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
a2a7abea-ce87-4c87-8689-e608babc36ac
Public Version Date
January 20, 2020
Public Version Number
2
DI Record Publish Date
November 29, 2018
Package DI Number
00372217007333
Quantity per Package
5
Contains DI Package
00372217007081
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |