AS Columbus®

Basic Information

• Brand Name: AS Columbus®
• Primary DI: 04046963367688
• Version / Model: NN584Z
• Catalog Number: NN584Z
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 5
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: b91a3251-0c50-456e-9c4e-ba8f06328c7b

Device Description

AS COLUMBUS TIB.HEMI-SP.T1/1+ 8MM RL/LM

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
48067	Knee arthroplasty wedge	An implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046963367688	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Implant Fixation : cemented
Device Size Text, specify			Height : 8.000 MM
Device Size Text, specify			Figure / Size : T1/T1+
Device Size Text, specify			Anatomic Term : right lateral / left medial