RING-LOK

Basic Information

• Brand Name: RING-LOK
• Primary DI: 05051693307629
• Version / Model: Modular Bi-Polar (46mm- 28mm Head)
• Catalog Number: BP2372
• 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: 90de4ce3-fb48-49e9-a245-93b9ed634253

Device Description

Modular Bi-Polar 46mm Dia. (28mm Head) For Uncemented Applications

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
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	888.3390	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	05051693307629	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	46	Millimeter

Storage Conditions

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