Catalog Number

-

Brand Name

Strauss Surgical

Version/Model Number

STS-ACC-6000-BRGA-002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K992527

Product Code

FGB

Product Code Name

Ureteroscope And Accessories, Flexible/Rigid

Public Device Record Key

b3c1ee67-54aa-4d95-a781-02033b0f7605

Public Version Date

January 19, 2022

Public Version Number

3

DI Record Publish Date

December 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-