Duns Number:024723541
Device Description: UltiCare 8mm x 31G, 5ct
Catalog Number
-
Brand Name
UltiCare 8mm pen needle 5-pk
Version/Model Number
99583
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"
Yes
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
K100812,K100812,K100812
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
1e39b66e-4873-45e5-bd92-c30879ea8eb1
Public Version Date
October 18, 2019
Public Version Number
1
DI Record Publish Date
October 10, 2019
Package DI Number
30357515995835
Quantity per Package
300
Contains DI Package
10357515710052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |