Catalog Number

AT7511-WE

Brand Name

CONVERTORS

Version/Model Number

AT7511-WE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

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"

Yes

For Single-Use

Yes

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

-

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

9ecd2329-fd86-4531-98f7-17e46ce25034

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

July 26, 2016

Package DI Number

50885380072190

Quantity per Package

4

Contains DI Package

20885380072199

Package Discontinue Date

January 01, 2025

Package Status

In Commercial Distribution

Package Type

CASE