Catalog Number

10.505.2040

Brand Name

DynaMatrix Plus

Version/Model Number

G56903

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K082058,K161762

Product Code

NPL

Product Code Name

Barrier, animal source, intraoral

Public Device Record Key

79f15d09-c809-4b58-87a9-bca3015a36a4

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-