Catalog Number

-

Brand Name

CER-RMR-11

Version/Model Number

11GA X 8.4"

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

HTO

Product Code Name

Reamer

Public Device Record Key

01103ff5-7703-4f85-8f5c-86173f91b967

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Package DI Number

10850023741124

Quantity per Package

1

Contains DI Package

00850023741127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack