Catalog Number

-

Brand Name

RibLoc

Version/Model Number

RBL1304

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2021

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"

-

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

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

54c2eba4-a30e-4021-a04c-944a6647fc59

Public Version Date

April 12, 2021

Public Version Number

3

DI Record Publish Date

September 10, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-