OMNI ARC Hip - ARC Femoral Stem Size 1, 8 degree Varus- Short HA - Omni Life Science, Inc.

Duns Number:061339651

Device Description: ARC Femoral Stem Size 1, 8 degree Varus- Short HA Coated

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More Product Details

Catalog Number

HC-24001-HA

Brand Name

OMNI ARC Hip

Version/Model Number

HC-24001-HA

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

KWY

Product Code Name

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

Device Record Status

Public Device Record Key

3249ef48-db91-4a8b-8320-01e6f60cc2f0

Public Version Date

September 13, 2021

Public Version Number

3

DI Record Publish Date

November 27, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OMNI LIFE SCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1365