Catalog Number

-

Brand Name

Centurion

Version/Model Number

CRB1030

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

FHG

Product Code Name

BELL, CIRCUMCISION

Public Device Record Key

b5fc34a2-9d37-47ba-a69a-2d1460bf7462

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 07, 2016

Package DI Number

00653160274776

Quantity per Package

20

Contains DI Package

10653160274773

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE