OMNI Interface Acetabular System - ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, - Omni Life Science, Inc.

Duns Number:061339651

Device Description: ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, F Insert/36mm ID

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More Product Details

Catalog Number

H5-45236

Brand Name

OMNI Interface Acetabular System

Version/Model Number

H5-45236

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

LPH

Product Code Name

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Record Status

Public Device Record Key

195fa4e2-b7c9-4053-b96e-afe451ead251

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