Catalog Number

-

Brand Name

Kopis Knotless Anchor

Version/Model Number

F-31-16520

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

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

2b46d80a-e812-4f45-bd31-93d9716649de

Public Version Date

May 18, 2022

Public Version Number

1

DI Record Publish Date

May 10, 2022

Package DI Number

10818614022540

Quantity per Package

5

Contains DI Package

00818614022543

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box