Duns Number:080935429
Device Description: Hydrogel Coated Latex Foley Catheter,Coude Tip, 30 mL, 2-Way
Catalog Number
1418C
Brand Name
Dover
Version/Model Number
1418C
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)
Yes
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
EZL
Product Code Name
CATHETER, RETENTION TYPE, BALLOON
Public Device Record Key
71cd4a7c-a654-4a16-9e83-682f318cc059
Public Version Date
November 09, 2020
Public Version Number
9
DI Record Publish Date
October 13, 2016
Package DI Number
30884521015825
Quantity per Package
12
Contains DI Package
10884521015821
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |