Catalog Number

3953

Brand Name

Baebies C-Stop Solution

Version/Model Number

3673

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PPM

Product Code Name

General Purpose Reagent

Public Device Record Key

546070b4-f41d-4f49-b0d9-4f499c7aab8c

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 04, 2018

Package DI Number

10819704020323

Quantity per Package

12

Contains DI Package

00819704020326

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box