Catalog Number

AN75.74

Brand Name

Anprolene AN75 Ethylene Oxide Sterilizer, 115V

Version/Model Number

AN75.74

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

757c76d9-4769-43ee-ab2a-5ecb0a6afc85

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

-