Catalog Number

-

Brand Name

SpiraLith Ca

Version/Model Number

Rx-3719C

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

CBL

Product Code Name

Absorbent, Carbon-Dioxide

Public Device Record Key

45abc35b-79f4-4b41-aa30-9f54f4b16d39

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

10860008449839

Quantity per Package

6

Contains DI Package

00860008449832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box