Catalog Number

71932023

Brand Name

REFLECTION

Version/Model Number

71932023

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2016

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)

-

FDA Premarket Submission

K960094

Product Code

MBL

Product Code Name

Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Public Device Record Key

c3d5b8c7-f5b3-4ad6-b275-1b1ec858fcae

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

September 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-