MultiCup™ PE Inlay Standard

Basic Information

• Brand Name: MultiCup™ PE Inlay Standard
• Primary DI: 04048266135780
• Version / Model: Size 41 Head 28
• Catalog Number: HF74128
• Company Name: Merete GmbH
• Labeler DUNS: 313267265
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-01
• Public Version: 8
• Public Version Date: 2023-05-12
• Public Version Status: Update
• Public Device Record Key: 55c28551-87b9-4186-b01a-fc0e1813c509
• Distribution End Date: 2021-12-13

Device Description

MultiCup™ PE Inlay Standard, Size 41 Head 28 UHMWPE sterile

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
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	888.3353	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
Primary	04048266135780	GS1

Customer Contacts

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