Duns Number:065762392
Device Description: Pre-Connected Latex Foley Tray 16FR
Catalog Number
UR1416FT
Brand Name
Biotronix Healthcare Foley Trays
Version/Model Number
UR1416FT
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
OHR
Product Code Name
Catheter Care Tray
Public Device Record Key
451e1527-bbed-4ede-a7bc-158419d86f03
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
October 05, 2019
Package DI Number
10864085000495
Quantity per Package
10
Contains DI Package
00864085000498
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |