Catalog Number

MNS12335

Brand Name

Centurion

Version/Model Number

MNS12335

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

KNA

Product Code Name

Instrument, manual, specialized obstetric-gynecologic

Public Device Record Key

d36f5009-ced3-4959-98ca-a731b864d976

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Package DI Number

00653160331103

Quantity per Package

10

Contains DI Package

10653160331100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE