Catalog Number

-

Brand Name

BioWrap

Version/Model Number

17-04-155714

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K782055,K782055

Product Code

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

2dca3d21-dbb3-4e8d-a0f1-919347340616

Public Version Date

October 19, 2021

Public Version Number

1

DI Record Publish Date

October 11, 2021

Package DI Number

10855683006859

Quantity per Package

128

Contains DI Package

00855683006852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case