Catalog Number

S123136

Brand Name

Selex®

Version/Model Number

S123136

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

-

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

K062997

Product Code

LZO

Product Code Name

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Public Device Record Key

52404b29-6b0a-42e1-ab99-1a55815e463c

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-