Catalog Number

-

Brand Name

OSTEO-Derm

Version/Model Number

OSTEOD15x20

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

NPL

Product Code Name

Barrier, Animal Source, Intraoral

Public Device Record Key

cb4ef71c-cdf5-4d73-b36c-c4cba407062b

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-