Omni-Fit

Basic Information

• Brand Name: Omni-Fit
• Primary DI: 05051693303874
• Version / Model: Modular Femoral Head LN (36mm Dia.)
• Catalog Number: FH3122
• Company Name: IMPLANTS INTERNATIONAL LTD
• Labeler DUNS: 346627222
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-31
• Public Version: 3
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: 84b47138-5958-446e-b4f8-ec803dc61d60

Device Description

Modular Femoral Head LN (Cobalt Chrome) 36mm Dia ( +3.5)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33175	Metallic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051693303874	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	36	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room temperature and Dry