Catalog Number

338112

Brand Name

UNIFAST™

Version/Model Number

338112

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

K890829,K890829

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

64b4eab7-e049-45df-85e5-576abb577c83

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

D6583381122

Quantity per Package

5

Contains DI Package

D6583381121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton