Duns Number:130789944
Device Description: Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Genesis U Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Genesis Urological Table
Catalog Number
10501000
Brand Name
Dornier MedTech
Version/Model Number
Dornier Genesis Urology Drain Bag
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
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
11f05c49-a834-4fdd-8e44-ce4e1543c05f
Public Version Date
April 09, 2020
Public Version Number
1
DI Record Publish Date
April 01, 2020
Package DI Number
10810116023032
Quantity per Package
20
Contains DI Package
00810116023035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |