Catalog Number

10207

Brand Name

Sterrad

Version/Model Number

10207

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 11, 2020

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

-

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

Product Code

MLR

Product Code Name

Sterilizer, chemical

Public Device Record Key

a8387a97-dfab-4670-96d0-46f67c1dbc07

Public Version Date

December 11, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-