Duns Number:187129135
Device Description: Ureteral Dilating Catheter
Catalog Number
-
Brand Name
Forté® AXP Access Sheath
Version/Model Number
B7286
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)
-
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
FED
Product Code Name
Endoscopic Access Overtube, Gastroenterology-Urology
Public Device Record Key
d3a698da-a8bd-4738-8cc7-67403a31ac46
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 15, 2016
Package DI Number
10607915113534
Quantity per Package
6
Contains DI Package
00607915113537
Package Discontinue Date
-
Package Status
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 |