Catalog Number

SC00124

Brand Name

CALICO

Version/Model Number

SC00124

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

-

Product Code

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

dee48e1e-905b-48c6-a6d0-5e1b8ada59f7

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Package DI Number

20850044458695

Quantity per Package

10

Contains DI Package

00850044458691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case