Duns Number:017246562
Device Description: STERILE SPECIMEN BOWL WITH LID
Catalog Number
UB404LST
Brand Name
Centurion
Version/Model Number
UB404LST
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)
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
2ad6b1d8-849e-484a-8ef3-1fdc7dddf455
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
January 02, 2022
Package DI Number
10653160137764
Quantity per Package
20
Contains DI Package
00653160137767
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 | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |