Duns Number:848917027
Device Description: 90ml Sterile Urine Specimen Cup PK400
Catalog Number
-
Brand Name
Marketlab
Version/Model Number
108190
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)
Yes
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
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
d5f5b50c-1650-4820-ab11-e0bf4d3aecf5
Public Version Date
October 20, 2022
Public Version Number
1
DI Record Publish Date
October 12, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |