Catalog Number

AN75.75

Brand Name

Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V

Version/Model Number

AN75.75

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K170432

Product Code

FLF

Product Code Name

Sterilizer, Ethylene-Oxide Gas

Public Device Record Key

dc8ea815-eba6-4332-ad8a-ed918fa745f3

Public Version Date

August 24, 2020

Public Version Number

1

DI Record Publish Date

August 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-