Catalog Number

-

Brand Name

RH-Pro11

Version/Model Number

RH-Pro11

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

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

K881371

Product Code

KMH

Product Code Name

Sterilizer, Dry Heat

Public Device Record Key

5fb5dc22-d989-46df-9f80-c20dd8cf5136

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-