Catalog Number

-

Brand Name

QuickDraw

Version/Model Number

988-1200

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

8cdf6e2d-5395-4782-ac78-9b2404f491e5

Public Version Date

July 09, 2019

Public Version Number

1

DI Record Publish Date

July 01, 2019

Package DI Number

30850008316013

Quantity per Package

20

Contains DI Package

10850008316019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box