Duns Number:024723541
Device Description: 09355 .5cc 30G 1/2"
Catalog Number
-
Brand Name
UltiCare
Version/Model Number
0355PL
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
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
fedcd99b-9aa5-4728-9519-81fa4e3865fd
Public Version Date
April 09, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20357515093558
Quantity per Package
10
Contains DI Package
10357515193558
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |