Duns Number:001061233
Device Description: Dale Urodynamic Tube Holder, Fits most
Catalog Number
490
Brand Name
Dale Urodynamic Tube Holder
Version/Model Number
490
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
6c320fdb-9834-4721-86cc-9362d7c94c15
Public Version Date
January 30, 2020
Public Version Number
3
DI Record Publish Date
August 30, 2018
Package DI Number
H84104902
Quantity per Package
50
Contains DI Package
H84104901
Package Discontinue Date
December 31, 2019
Package Status
Not 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 | 74 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |