Catalog Number

-

Brand Name

QuickDraw

Version/Model Number

988-1000

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

67ac81d8-8c5a-47db-a630-12e53471face

Public Version Date

July 09, 2019

Public Version Number

1

DI Record Publish Date

July 01, 2019

Package DI Number

30850008316020

Quantity per Package

20

Contains DI Package

10850008316026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box