Catalog Number

CXT1145S

Brand Name

CELLXTRACT Autologous Cell and Bone Marrow Extraction

Version/Model Number

CXT1145S 11GA X 11CM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

f8695c32-814e-40e1-9a74-04816e1bc448

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 27, 2018

Package DI Number

M979CXT1145S9

Quantity per Package

30

Contains DI Package

M979CXT1145S1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case