Catalog Number

020989

Brand Name

RD® QUICK LOAD®

Version/Model Number

020989

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

K031443,K100593,K203120,K031443,K100593,K203120

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

337d82c6-0272-4808-a5cb-49f180100098

Public Version Date

August 16, 2021

Public Version Number

8

DI Record Publish Date

December 04, 2015

Package DI Number

10850200006312

Quantity per Package

12

Contains DI Package

00850200006315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack