Catalog Number

I68925

Brand Name

Centurion

Version/Model Number

I68925

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

HDQ

Product Code Name

DILATOR, CERVICAL, FIXED SIZE

Public Device Record Key

dd13c89d-bf59-44cc-b56a-8f1cd7436632

Public Version Date

April 05, 2022

Public Version Number

1

DI Record Publish Date

March 28, 2022

Package DI Number

00653160351286

Quantity per Package

20

Contains DI Package

10653160351283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE