Duns Number:080935429
Device Description: 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor,5 mL
Catalog Number
50518ICT
Brand Name
Dover
Version/Model Number
50518ICT
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
EZL
Product Code Name
CATHETER, RETENTION TYPE, BALLOON
Public Device Record Key
7f22ef5f-af2b-41bf-946b-a6e6f383a6c4
Public Version Date
December 04, 2020
Public Version Number
10
DI Record Publish Date
September 24, 2016
Package DI Number
10884521149236
Quantity per Package
12
Contains DI Package
30884521149230
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 |