Catalog Number

L-11092

Brand Name

QUICK-DIE CARTRIDGE

Version/Model Number

L-11092

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 03, 2019

Issuing Agency

In HIBCC

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

-

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

K962680

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

67b71346-a370-4533-a74b-d3e69d1b2850

Public Version Date

April 04, 2019

Public Version Number

2

DI Record Publish Date

November 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-