Catalog Number

70-BIO-DWD10

Brand Name

Newport Biologics Resorbable Collagen Plug

Version/Model Number

70-BIO-DWD10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

KGN

Product Code Name

DRESSING, WOUND, COLLAGEN

Public Device Record Key

a81809b2-de2f-4589-8bd5-6a73176b3028

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

D74570BIODWD101

Quantity per Package

10

Contains DI Package

D74570BIODWD100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-