ENDURO

Basic Information

• Brand Name: ENDURO
• Primary DI: 04046964010408
• Version / Model: NR885M
• Catalog Number: NR885M
• 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: 2021-04-12
• Public Version Status: Update
• Public Device Record Key: 5de13fda-bd8b-4a25-a1b4-fc96c60583c0
• Distribution End Date: 2018-11-04

Device Description

ENDURO MENISCAL COMPONENT F2 20MM

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
33692	Rotating hinged total knee prosthesis	A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964010408	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Figure / Size : F2
Device Size Text, specify			Height : 20.000 MM