Catalog Number

25410

Brand Name

ASP AERO-OPA

Version/Model Number

25410

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181472,K181472

Product Code

MED

Product Code Name

Sterilant, medical devices

Public Device Record Key

7ce061cc-43eb-4b65-8937-3b346fcdd043

Public Version Date

March 19, 2021

Public Version Number

5

DI Record Publish Date

July 31, 2019

Package DI Number

20705037048882

Quantity per Package

4

Contains DI Package

10705037048885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case