Duns Number:187129135
Device Description: Kit Contains:B1005, ACUCISE® ENDOPYELOTOMY SYSTEMB7016, FORTE AxP SET 12/14/18F 35CM 6/BXB Kit Contains:B1005, ACUCISE® ENDOPYELOTOMY SYSTEMB7016, FORTE AxP SET 12/14/18F 35CM 6/BXB3306, STENT, C-FLEX 7/10F x 20 CM
Catalog Number
-
Brand Name
ACUCISE® PROCEDURAL PACK
Version/Model Number
BK021
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 13, 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"
Yes
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
9fff6720-2bc4-45a3-a65a-6950b56500fb
Public Version Date
February 08, 2019
Public Version Number
4
DI Record Publish Date
October 09, 2015
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 | 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 |