MRS - Humeral Module - Howmedica Osteonics Corp.

Duns Number:058311945

Device Description: Humeral Module

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More Product Details

Catalog Number

6487-3-075

Brand Name

MRS

Version/Model Number

6487-3-075

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K954559

Product Code Details

Product Code

HSD

Product Code Name

PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Device Record Status

Public Device Record Key

7463ef62-7d08-4fd5-aa5e-66ee2de14742

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOWMEDICA OSTEONICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5091
2 A medical device with a moderate to high risk that requires special controls. 10216
3 A medical device with high risk that requires premarket approval 32