Consensus® Hip System - Bipolar Assembly - CONSENSUS ORTHOPEDICS, INC.

Duns Number:824905723

Device Description: Bipolar Assembly

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More Product Details

Catalog Number

1020-0-3846

Brand Name

Consensus® Hip System

Version/Model Number

1020-0-3846

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2021

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KWY

Product Code Name

Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Device Record Status

Public Device Record Key

4f0bf7c4-7587-48fd-96ca-622b686b4f98

Public Version Date

July 29, 2021

Public Version Number

4

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

-

"CONSENSUS ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 2053
3 A medical device with high risk that requires premarket approval 85