Catalog Number

339291

Brand Name

UNIFAST™

Version/Model Number

339291

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

K984365,K984365

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

d8e95a64-e840-4ec2-9041-0e2e3cd3ef2e

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Package DI Number

20386040000984

Quantity per Package

10

Contains DI Package

10386040000987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton