Catalog Number

71271600

Brand Name

RALLY

Version/Model Number

71271600

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K143100

Product Code

LOD

Product Code Name

BONE CEMENT

Public Device Record Key

9e705ff5-52df-4119-9c99-4f334700612f

Public Version Date

January 31, 2020

Public Version Number

4

DI Record Publish Date

October 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-