CORAIL

Basic Information

• Brand Name: CORAIL
• Primary DI: 10603295262299
• Version / Model: L98010
• Catalog Number: L98010
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 7
• Public Version Date: 2022-01-11
• Public Version Status: Update
• Public Device Record Key: 8427fbf0-13f7-4e66-b742-83bda7bceccb

Device Description

CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED REVISION 12/14 AMT 135 DEGREES STANDARD COLLAR SIZE 10

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
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate	Orthopedic	888.3353	2
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented	Orthopedic	888.3360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34032	Revision coated hip femur prosthesis	A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295262299	GS1

Customer Contacts

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