Duns Number:080935429
Device Description: Silver Coated 100% Silicone Foley Insertion Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter
Catalog Number
2116IC
Brand Name
Dover
Version/Model Number
2116IC
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
Yes
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
6e5ffc8d-387a-4a9a-8c33-67f991e6c69e
Public Version Date
December 04, 2020
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
30884521003402
Quantity per Package
20
Contains DI Package
10884521003408
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |