Catalog Number

1016-C30

Brand Name

MEDICOM DURAFLOR ULTRA

Version/Model Number

1016-C30

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"

Yes

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

5776c368-1069-4a37-9db2-59cddea43507

Public Version Date

January 09, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

20686864040976

Quantity per Package

6

Contains DI Package

10686864040979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK