Catalog Number

SPS12STA

Brand Name

Centurion

Version/Model Number

SPS12STA

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

EFW

Product Code Name

TOOTHBRUSH, MANUAL

Public Device Record Key

27795b49-67f5-4dc9-bc37-c7ce444d34ef

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Package DI Number

10653160106111

Quantity per Package

100

Contains DI Package

00653160106114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE