Catalog Number

-

Brand Name

Centurion

Version/Model Number

PE410

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

MLT

Product Code Name

Pelvic exam kit

Public Device Record Key

ab3cea80-6f8f-4a9c-a7bb-62b2d178f14b

Public Version Date

January 16, 2019

Public Version Number

3

DI Record Publish Date

November 11, 2016

Package DI Number

50653160014537

Quantity per Package

20

Contains DI Package

00653160014532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE