Catalog Number

ST475-333-000

Brand Name

Sustainable Technologies

Version/Model Number

ST475-333-000

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

K172092

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

ba2e6899-9ce2-4b8a-afd6-72b5a6bd9435

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

December 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-