Duns Number:187129135
Device Description: General Purpose Ureteral Catheter
Catalog Number
-
Brand Name
Acucise® Endopyelotomy System
Version/Model Number
B1201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 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
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
EYB
Product Code Name
Catheter, Ureteral, Gastro-Urology
Public Device Record Key
577596af-3c5f-4648-aa80-ed9a2bd61f85
Public Version Date
April 15, 2019
Public Version Number
4
DI Record Publish Date
August 22, 2016
Package DI Number
10607915111677
Quantity per Package
1
Contains DI Package
00607915111670
Package Discontinue Date
March 25, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |