Duns Number:316957240
Device Description: Insertion sleeve, for suprapubic overflow controller
Catalog Number
A2247
Brand Name
Olympus
Version/Model Number
A2247
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2019
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
-
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
K904798
Product Code
KOB
Product Code Name
Catheter, Suprapubic (And Accessories)
Public Device Record Key
389a16dc-048f-4a13-990c-83303cf28aec
Public Version Date
August 04, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1109 |