Catalog Number

9002213

Brand Name

CUSTOMED

Version/Model Number

712057462213

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

023812d3-2c6e-42e5-a9b3-c47f7c225b87

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

M20890022132

Quantity per Package

6

Contains DI Package

M20890022131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

50/BOX 6BOX/CS