CS2 Acetabular Cup System

Basic Information

• Brand Name: CS2 Acetabular Cup System
• Primary DI: 00840286810173
• Version / Model: 1716-0-0058
• Catalog Number: 1716-0-0058
• Company Name: Shalby Advanced Technologies, Inc.
• Labeler DUNS: 085976260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-20
• Public Version: 1
• Public Version Date: 2022-01-28
• Public Version Status: New
• Public Device Record Key: 2f7b4d59-760b-4a84-a943-22723eaef674

Device Description

Acetabular Shell, Multi-Hole, Hemi, Cementless, PC, 58mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LHP	System, telethermographic (sole diagnostic screen)	Obstetrics/Gynecology	884.2980	3

GMDN Terms

Code	Name	Definition	Implantable	Status
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840286810173	GS1

Customer Contacts

• Phone: [phone] ext. 155
• Email: [email protected]