Catalog Number

2142

Brand Name

MEDICOM SAFEBASICS

Version/Model Number

2142

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"

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

bf213963-1520-4585-803d-e82af3c0c040

Public Version Date

May 03, 2022

Public Version Number

5

DI Record Publish Date

November 25, 2016

Package DI Number

20686864044875

Quantity per Package

10

Contains DI Package

10686864044878

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE