Duns Number:080935429
Device Description: 100% Silicone Foley Catheter 5-10 mL, 2-Way
Catalog Number
8887605205
Brand Name
Dover
Version/Model Number
8887605205
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
1bb7cf60-122e-4f18-9c83-b0551adfa2c0
Public Version Date
February 23, 2021
Public Version Number
12
DI Record Publish Date
May 15, 2017
Package DI Number
10884521011854
Quantity per Package
10
Contains DI Package
10884521516786
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 |