Perfecta

Basic Information

• Brand Name: Perfecta
• Primary DI: M68475650001001
• Version / Model: 7565000100
• Catalog Number: 7565000100
• Company Name: Microport Orthopedics Inc.
• Labeler DUNS: 079118736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 07a2ea37-6a61-41a8-9cd6-fb0e4824d62f

Device Description

UHMWPE CEMENT RESTRICTOR SMALL FITS CANALS 11-17mm

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
LZN	Cement Obturator	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61271	Femoral stem centralizer	A small sterile implantable device intended to be used during the implantation of a cemented femoral stem prosthesis to centralize and stabilize the prosthesis tip within the femoral medullary canal; it is inserted into the medullary canal prior to cement insertion. It is made of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] and may have a winged structure.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	7565000100	HIBCC
Primary	M68475650001001	HIBCC

Customer Contacts

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