ACS®

Basic Information

• Brand Name: ACS®
• Primary DI: 04048844108298
• Version / Model: 42010464
• Company Name: implantcast GmbH
• Labeler DUNS: 324369826
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-23
• Public Version: 1
• Public Version Date: 2024-10-01
• Public Version Status: New
• Public Device Record Key: f4c534ec-2816-445e-976e-97f3a9ad7f57

Device Description

double taper

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62865	Knee femur stem/sleeve connector	A sterile implantable device intended to provide a connection between a knee femur prosthesis and a knee stem or sleeve when the knee femur prosthesis does not have a connection point inherent in its design. It takes various forms including a plate and trunnion, or a cylinder, and is made of metal [e.g., cobalt-chrome (Co-Cr)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048844108298	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4mm