Duns Number:305971764
Device Description: UNIVERSALCONT.25ML CAP,SPOON.LABEL SI
Catalog Number
-
Brand Name
UNIVERSALCONT.25ML CAP,SPOON LABEL SI
Version/Model Number
360585
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
-
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
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
d3e8d102-9432-4e42-8e53-09621a55c4cc
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
August 17, 2018
Package DI Number
05713311000090
Quantity per Package
6
Contains DI Package
15713311000097
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 |