Catalog Number

-

Brand Name

Centurion

Version/Model Number

CR230K

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

K890897,K890897

Product Code

HFX

Product Code Name

CLAMP, CIRCUMCISION

Public Device Record Key

2c1cfd64-cec4-41bd-9a92-8606c647fac0

Public Version Date

May 04, 2020

Public Version Number

3

DI Record Publish Date

October 14, 2017

Package DI Number

00653160312898

Quantity per Package

12

Contains DI Package

10653160312895

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE