Duns Number:153880372
Device Description: Urine Specimen Container
Catalog Number
-
Brand Name
Plasti Products
Version/Model Number
PlastiPan1050
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
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
FOB
Product Code Name
Bedpan
Public Device Record Key
360fb743-c452-4177-8806-a92e1a128e8e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 15, 2016
Package DI Number
40797876110503
Quantity per Package
100
Contains DI Package
10797876110502
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |