Catalog Number

BIO-XCP

Brand Name

Bio-XC™ Plug

Version/Model Number

BIO-XCP

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

b2bb5490-dd33-489f-9cd2-ffefb51e3d51

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

September 26, 2019

Package DI Number

20841307123702

Quantity per Package

10

Contains DI Package

10841307123705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Chipboard Carton