Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 48 MM DIA X 21 MM HEIGHT - INGEN ORTHOPEDICS, L.L.C.

Duns Number:187232066

Device Description: HUMERAL HEAD, STANDARD, 48 MM DIA X 21 MM HEIGHT

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More Product Details

Catalog Number

101-48-21

Brand Name

Ingen SEVIIN® Shoulder System

Version/Model Number

101-48-21

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

KWS

Product Code Name

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

Device Record Status

Public Device Record Key

f2221b77-9b8b-4df5-b8a1-4986d0928fa1

Public Version Date

March 28, 2019

Public Version Number

1

DI Record Publish Date

March 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INGEN ORTHOPEDICS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 61