DURAMER®

Basic Information

• Brand Name: DURAMER®
• Primary DI: M68436912852001
• Version / Model: 3691285200
• Catalog Number: 3691285200
• Company Name: Microport Orthopedics Inc.
• Labeler DUNS: 079118736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2203fcd0-e160-4f41-ac3f-b49f2681819d

Device Description

DURAMER® ALL POLY CUP 52mm OD 28mm ID

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: Yes
• 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
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	888.3400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43168	Non-constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	3691285200	HIBCC
Primary	M68436912852001	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	52	Millimeter
Lumen/Inner Diameter	28	Millimeter