Catalog Number

100-04-01

Brand Name

Ingen SEVIIN® Shoulder System

Version/Model Number

100-04-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K043346

Product Code

KWS

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Public Device Record Key

10ea57f8-d3f3-464b-9525-4fca42f25545

Public Version Date

March 28, 2019

Public Version Number

1

DI Record Publish Date

March 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-