Catalog Number

338113

Brand Name

UNIFAST™

Version/Model Number

338113

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

K890829,K890829

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

adb4925c-b3f9-44d8-b662-b20b428e5084

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Package DI Number

20386040006658

Quantity per Package

5

Contains DI Package

10386040006651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton