Catalog Number

Y1SOB1

Brand Name

Y-Knot, OneStep

Version/Model Number

Y1SOB1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 17, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NBH

Product Code Name

Accessories, arthroscopic

Public Device Record Key

2a9d4588-b10b-47e8-b5b2-8cdf21becbae

Public Version Date

October 19, 2020

Public Version Number

2

DI Record Publish Date

April 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-