Catalog Number

10133

Brand Name

Sterrad

Version/Model Number

10133

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042116,K142454,K042116,K142454

Product Code

MLR

Product Code Name

Sterilizer, chemical

Public Device Record Key

2ef7ae07-9b67-4f04-841f-9092e3d94e17

Public Version Date

December 11, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20705037014832

Quantity per Package

5

Contains DI Package

10705037014835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case