Catalog Number

01-201104-L

Brand Name

STATIM 5000 Cassette Autoclave

Version/Model Number

01-201104-L

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

b57d5100-a8cc-4360-8f20-bec18d2c4127

Public Version Date

December 18, 2018

Public Version Number

4

DI Record Publish Date

January 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-