Duns Number:187129135
Device Description: Kit Includes:B1201, URO TAMPONADE BALLOON CATHH-110, HANDLE 10CC LFSEAL-005, SURESEAL II, Kit Includes:B1201, URO TAMPONADE BALLOON CATHH-110, HANDLE 10CC LFSEAL-005, SURESEAL II, INT. BOX/10, CEUROWIRE
Catalog Number
-
Brand Name
Acucise® Endopyelotomy System
Version/Model Number
B1005
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 28, 2018
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
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
c94f427d-4fe7-420f-b9d3-d4695844182d
Public Version Date
April 15, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10607915111660
Quantity per Package
1
Contains DI Package
00607915111663
Package Discontinue Date
October 28, 2018
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 |