Catalog Number

-

Brand Name

ASP MEDICAL

Version/Model Number

FMT655

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182515,K182515,K182515

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

0fe853af-1182-4cca-8d9d-f8ef11b6e968

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 21, 2020

Package DI Number

10840216108971

Quantity per Package

50

Contains DI Package

00840216108974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER BOX