Catalog Number

032500

Brand Name

COR-KNOT MICRO™

Version/Model Number

032500

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

K202551,K202551

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

cf120bc8-0efa-44c6-b121-038b27d3f42a

Public Version Date

August 16, 2021

Public Version Number

2

DI Record Publish Date

July 14, 2021

Package DI Number

10850200006930

Quantity per Package

6

Contains DI Package

00850200006933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack