Catalog Number

SIH0005

Brand Name

STERICADI™ SUCTION DEVICE HOLDER KIT

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

def64570-2471-42e9-b076-58c510726aa9

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

40704411001400

Quantity per Package

30

Contains DI Package

10704411001409

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case