b-ONE™ Primary Acetabular System

Basic Information

• Brand Name: b-ONE™ Primary Acetabular System
• Primary DI: 00843575104014
• Version / Model: 881906428G
• Catalog Number: 881906428G
• Company Name: B-ONE ORTHO, CORP.
• Labeler DUNS: 081315444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-15
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 69d3b842-2494-4e1a-a716-69b351539597

Device Description

ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE G X 28MM I.D.

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWT	Template	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58480	Acetabulum prosthesis trial, prefabricated, reusable	A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843575104014	GS1