AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04038653299492
• Version / Model: NO486
• Catalog Number: NO486
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 3
• Public Version Date: 2021-05-21
• Public Version Status: Update
• Public Device Record Key: 9db4e71b-7916-4815-85f4-395bffa1fbbe
• Distribution End Date: 2021-05-07

Device Description

E.MOTION PATELLA 3-PEGS P6 41X12MM

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
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32841	Mobile-bearing total knee prosthesis	A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)] or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for rotation to minimize wear/loosening problems and to allow greater range of motion for the joint than other types of knee prostheses. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used for younger and/or active patients.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038653299492	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter (mm) : 41.000 MM
Device Size Text, specify			Implant Fixation : cemented
Device Size Text, specify			Height : 12.000 MM
Device Size Text, specify			Figure / Size : P6