COR-KNOT MINI® - COR-KNOT MINI® DEVICE KITBase Package Type - - LSI Solutions, Inc.

Duns Number:603420183

Device Description: COR-KNOT MINI® DEVICE KITBase Package Type - KitEach sterile package kit contains (2) sing COR-KNOT MINI® DEVICE KITBase Package Type - KitEach sterile package kit contains (2) single patient use COR-KNOT MINI® Devices only.Rotating shaft.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

031300

Brand Name

COR-KNOT MINI®

Version/Model Number

031300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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,K100593

Product Code Details

Product Code

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Device Record Status

Public Device Record Key

d61b071a-be05-4066-8046-b6cf0df9a9f4

Public Version Date

July 16, 2020

Public Version Number

5

DI Record Publish Date

February 04, 2016

Additional Identifiers

Package DI Number

10850200006077

Quantity per Package

6

Contains DI Package

00850200006070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"LSI SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 56
2 A medical device with a moderate to high risk that requires special controls. 31