Catalog Number

UBLBPP

Brand Name

Ultra Band Lok

Version/Model Number

UBLBPP

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

-

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

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

e968835b-aaf0-420d-a482-f1b3439515cc

Public Version Date

October 29, 2018

Public Version Number

4

DI Record Publish Date

July 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-