Catalog Number

-

Brand Name

Ribbond Bondable Reinfocement Ribbon Kit

Version/Model Number

Original

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K913040,K913040

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

a1cdcfe4-18ae-4f7b-933e-73c4632d2632

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

D758OK1

Quantity per Package

3

Contains DI Package

D758OK0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-