Catalog Number

BIO-XCF

Brand Name

Bio-XC™ Foam

Version/Model Number

BIO-XCF

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"

Yes

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

e5cc164e-7246-4416-8a83-d41f103682c2

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

September 26, 2019

Package DI Number

20841307123696

Quantity per Package

10

Contains DI Package

10841307123699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Chipboard Carton