Catalog Number

D2 5.5 Channel Former

Brand Name

Tatum Channel Former D2 5.5mm

Version/Model Number

D2 5.5mm Channel former

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

-

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

EMM

Product Code Name

Chisel, Osteotome, Surgical

Public Device Record Key

329a21b6-8265-4ce6-baa7-33eed2384674

Public Version Date

April 22, 2020

Public Version Number

1

DI Record Publish Date

April 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-