Catalog Number

SM001

Brand Name

CALICO

Version/Model Number

SM001

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

K202191,K202191,K202191

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

477c3103-b314-4103-ae6c-54b6105efcdc

Public Version Date

September 14, 2022

Public Version Number

1

DI Record Publish Date

September 06, 2022

Package DI Number

20850044458909

Quantity per Package

40

Contains DI Package

00850044458905

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case