Catalog Number

550128

Brand Name

COECIDE™ XL

Version/Model Number

550128

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K931592,K931592

Product Code

MED

Product Code Name

Sterilant, medical devices

Public Device Record Key

f64c14a8-5b78-43be-b9ae-a44fb81407bc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

D6585501282

Quantity per Package

4

Contains DI Package

D6585501281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton