Catalog Number

520000032

Brand Name

INHANCE

Version/Model Number

5200-00-032

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

PAO

Product Code Name

prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Public Device Record Key

684c808b-30ff-4d51-abb9-7ce7f2ade015

Public Version Date

April 06, 2022

Public Version Number

2

DI Record Publish Date

November 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-