Catalog Number

1016-CH30

Brand Name

MEDICOM DURAFLOR ULTRA

Version/Model Number

1016-CH30

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

Yes

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

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

78ab2007-5d50-4c76-aa10-44e0fdd5105b

Public Version Date

April 19, 2022

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

20686864056502

Quantity per Package

6

Contains DI Package

10686864056505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK