Catalog Number

10.405.1520

Brand Name

DynaMatrix

Version/Model Number

G51300

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

d5e1dccc-9f5f-4b5e-895c-8ac0c7837e9f

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-