Catalog Number

-

Brand Name

Centurion

Version/Model Number

PE145

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

MLT

Product Code Name

Pelvic exam kit

Public Device Record Key

2a036841-26c2-43a6-8507-d60cf557a9bc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 11, 2016

Package DI Number

50653160001995

Quantity per Package

20

Contains DI Package

00653160001990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE