Catalog Number

55160

Brand Name

Centurion

Version/Model Number

55160

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

Yes

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

-

FDA Premarket Submission

-

Product Code

MCZ

Product Code Name

Suture removal kit

Public Device Record Key

d4646a0e-54f8-47fc-bf49-8bef9bc23589

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

50653160005283

Quantity per Package

30

Contains DI Package

00653160005288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE