Catalog Number

-

Brand Name

Moore Medical

Version/Model Number

82666

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061864,K061864,K061864

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

146ab91a-322e-4765-b732-f908e321b009

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

40607415001547

Quantity per Package

6

Contains DI Package

20607415001536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case