Catalog Number

-

Brand Name

Dentek

Version/Model Number

00038904806A

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OLR

Product Code Name

Oral Wound Dressing

Public Device Record Key

817aa1a0-e895-48db-aab8-040d17e9a5d6

Public Version Date

October 06, 2021

Public Version Number

2

DI Record Publish Date

October 06, 2020

Package DI Number

10047701001209

Quantity per Package

6

Contains DI Package

00047701001202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single