Catalog Number

Y1S2

Brand Name

Y-Knot, OneStep

Version/Model Number

Y1S2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 22, 2021

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

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

K193606

Product Code

MBI

Product Code Name

Fastener, fixation, nondegradable, soft tissue

Public Device Record Key

0f4b4299-04c0-488c-a27b-c20f6b42e9c4

Public Version Date

August 23, 2021

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

-