Catalog Number

9002214

Brand Name

CUSTOMED

Version/Model Number

712057462214

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081633,K081633,K081633

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

10e20586-15a1-4cc9-b036-a9b7704dba4a

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

M20890022142

Quantity per Package

10

Contains DI Package

M20890022141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

50/BOX, 10BOX/CS