Catalog Number

46660012

Brand Name

CANCELLO-PURE

Version/Model Number

46660012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2015

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

Yes

FDA Premarket Submission

-

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Public Device Record Key

9d7c634b-6b4c-40a5-a48f-59117f2e8225

Public Version Date

March 25, 2022

Public Version Number

4

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-