Duns Number:025460908
Device Description: DBD-1-LAYER DB TRAY SILI 18FR CN
Catalog Number
UROT1028
Brand Name
Medline
Version/Model Number
UROT1028
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
f3794397-71e8-4e47-a1ed-846b45349a65
Public Version Date
March 25, 2021
Public Version Number
1
DI Record Publish Date
March 17, 2021
Package DI Number
40889942537397
Quantity per Package
10
Contains DI Package
10889942537396
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |