Catalog Number

10113

Brand Name

Sterrad

Version/Model Number

10113

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

K023290,K991999,K023290,K991999

Product Code

FLF

Product Code Name

Sterilizer, ethylene-oxide gas

Public Device Record Key

591f3b2c-f7dc-4ef8-a122-7b4e226f7d9f

Public Version Date

December 11, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20705037014580

Quantity per Package

5

Contains DI Package

10705037014583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case