Catalog Number

031700

Brand Name

Mi-KNOT™

Version/Model Number

031700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K100593,K100593

Product Code

HCF

Product Code Name

INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Public Device Record Key

1a27168b-c1a1-4d2c-a0a3-eb330c0e35fa

Public Version Date

March 30, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2020

Package DI Number

10850200006534

Quantity per Package

6

Contains DI Package

00850200006537

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case