Catalog Number

231125

Brand Name

Proxis Ureteral Access Sheath

Version/Model Number

231125

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

f468aa51-a7bd-4d5c-9692-d5784b4bebda

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

December 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-