Catalog Number

-

Brand Name

OrthoButton AL

Version/Model Number

RP-OBAL-80

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"

-

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

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

f65c4481-4322-4a6e-88e1-0bbec1127e96

Public Version Date

May 29, 2019

Public Version Number

5

DI Record Publish Date

November 07, 2017

Package DI Number

10812444026242

Quantity per Package

10

Contains DI Package

00812444026245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-