Catalog Number

99-28-155446

Brand Name

Rebuilder

Version/Model Number

Rebuilder Electrolyte 1 gallon

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

-

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

5ac67787-f75d-4bd6-a661-180a230614b6

Public Version Date

July 09, 2021

Public Version Number

1

DI Record Publish Date

July 01, 2021

Package DI Number

10855683006668

Quantity per Package

1

Contains DI Package

00855683006661

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner