NOVAE E TH - NOVAE Dual Mobility Acetabular Cup - NOVAE E TH - SOC ETUDES RECHERCHES FABRICATION

Duns Number:282651413

Device Description: NOVAE Dual Mobility Acetabular Cup - NOVAE E TH metal-back cementlessNOVAE E TH has 3 fixa NOVAE Dual Mobility Acetabular Cup - NOVAE E TH metal-back cementlessNOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium)

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More Product Details

Catalog Number

-

Brand Name

NOVAE E TH

Version/Model Number

NOVAE E 45 TH

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

-

Product Code Details

Product Code

LZO

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Device Record Status

Public Device Record Key

f0391ef3-a71b-4c22-a50b-e7a43505bcd1

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOC ETUDES RECHERCHES FABRICATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 206