Catalog Number

99-25-155446

Brand Name

Rebuilder

Version/Model Number

Rebuilder Electrolyte 250 ml Spray

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

K780973,K780973,K780973

Product Code

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

d1c4c388-ea34-4383-a37b-1b62fe82d90e

Public Version Date

July 09, 2021

Public Version Number

1

DI Record Publish Date

July 01, 2021

Package DI Number

10855683006651

Quantity per Package

12

Contains DI Package

00855683006654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner