Catalog Number

2984

Brand Name

FIBRACOL® PLUS

Version/Model Number

2984

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

a9e4ed08-223a-4a75-b8bc-0ff1110fbea7

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

25051978001116

Quantity per Package

6

Contains DI Package

15051978001119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-