Duns Number:080186051
Device Description: Drain Bag used with Hydra Vision or Direct Digital Urology Systems
Catalog Number
-
Brand Name
LF
Version/Model Number
335563
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQS
Product Code Name
Table, Cystometric, Non-Electric And Accessories
Public Device Record Key
67ea0b30-9ae3-446f-8067-894b60e6c10b
Public Version Date
January 05, 2022
Public Version Number
3
DI Record Publish Date
September 10, 2020
Package DI Number
20746190002380
Quantity per Package
10
Contains DI Package
10746190002383
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |