Duns Number:961027315
Device Description: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 16 FR (5.3 MM)
Catalog Number
3601
Brand Name
Dover
Version/Model Number
3601
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
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
f3ef3d44-41ae-4467-9828-6d8bdd6f830a
Public Version Date
April 20, 2022
Public Version Number
1
DI Record Publish Date
April 12, 2022
Package DI Number
20192253026426
Quantity per Package
10
Contains DI Package
10192253026429
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |