Catalog Number

-

Brand Name

Tray Adhesive

Version/Model Number

DTA2

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

EBL

Product Code Name

Pin, Retentive And Splinting, And Accessory Instruments

Public Device Record Key

942cde4a-dd8b-42d1-bb1a-a041e976e2fc

Public Version Date

October 01, 2021

Public Version Number

1

DI Record Publish Date

September 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-