Catalog Number

MXC-2

Brand Name

Maxx Cell

Version/Model Number

11GA X 11CM

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

K150563,K150563,K150563

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

26d5d1a5-bed1-431f-a868-4418c1664b0f

Public Version Date

September 13, 2018

Public Version Number

1

DI Record Publish Date

August 13, 2018

Package DI Number

10857878007450

Quantity per Package

1

Contains DI Package

00857878007453

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner