Catalog Number

MNS9705

Brand Name

Centurion

Version/Model Number

MNS9705

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

FFQ

Product Code Name

SPECULUM, RECTAL

Public Device Record Key

9dc4b1f3-be80-437a-be92-4fab4e1b7b76

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Package DI Number

00653160286779

Quantity per Package

25

Contains DI Package

10653160286776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE