Catalog Number

BATIPS

Brand Name

Bond Aligner Tips

Version/Model Number

BATIPS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KXR

Product Code Name

Applicator, Resin

Public Device Record Key

1418e35b-229f-45cb-840a-912e3a3cf81f

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

July 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-