Duns Number:080935429
Device Description: 100% Silicone Foley Catheter,5-10 mL, 2-Way
Catalog Number
8887605221
Brand Name
Dover
Version/Model Number
8887605221
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
FCM
Product Code Name
Tray, catheterization, sterile urethral, with or without catheter (kit)
Public Device Record Key
b819121f-8312-46f8-83f1-550f777bbcaa
Public Version Date
February 23, 2021
Public Version Number
12
DI Record Publish Date
January 25, 2017
Package DI Number
00884521011871
Quantity per Package
10
Contains DI Package
00884521147563
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 |