Duns Number:001061233
Device Description: Dale Foley Catheter Holder, Leg band / Waist band, fits up to 56"
Catalog Number
330
Brand Name
Dale Foley Catheter Holder
Version/Model Number
330
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EYJ
Product Code Name
Holder, Ureteral Catheter
Public Device Record Key
9f3713c3-0d40-4869-a784-1ab4285a8a19
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
March 18, 2019
Package DI Number
00817612020599
Quantity per Package
10
Contains DI Package
00817612020582
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 | 74 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |