Duns Number:047644935
Device Description: Ureteral Access Sheath Stabilization System - includes: UAS Arm, Mount Post, Rail Clamp
Catalog Number
-
Brand Name
Flexarm Surgical Holders and Positioners
Version/Model Number
87009
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
e352d74f-aa80-4876-b650-63fb89ca552f
Public Version Date
August 19, 2022
Public Version Number
1
DI Record Publish Date
August 11, 2022
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 | 882 |
2 | A medical device with a moderate to high risk that requires special controls. | 595 |