Catalog Number

5094000

Brand Name

RCP Resorbable Collagen Plug

Version/Model Number

5094000

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

KGN

Product Code Name

DRESSING, WOUND, COLLAGEN

Public Device Record Key

0ee7420d-7b7d-43b9-b694-3c696fec55aa

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

10614950007216

Quantity per Package

10

Contains DI Package

00614950007219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvec Tray