Catalog Number

030510

Brand Name

TK® QUICK LOAD®

Version/Model Number

030510

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

98a6ae87-53b9-40c4-aec0-9675a0c10f92

Public Version Date

July 16, 2020

Public Version Number

4

DI Record Publish Date

December 04, 2015

Package DI Number

10850200006244

Quantity per Package

12

Contains DI Package

00850200006247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box / Inner Pack