Catalog Number

SL001, SL279

Brand Name

Sterilucent™ Sterilant Disc

Version/Model Number

SL001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140464,K140464,K140464

Product Code

MLR

Product Code Name

Sterilizer, Chemical

Public Device Record Key

a714ddaf-d8f5-4e72-b1ec-c2aebf0d800c

Public Version Date

May 07, 2020

Public Version Number

1

DI Record Publish Date

April 29, 2020

Package DI Number

00850012210030

Quantity per Package

5

Contains DI Package

00850012210023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5-Pack REF SL001