Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis 379.027

GUDID 05055196901650

CUP INTRODUCER HANDLE

CORIN LTD

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 05055196901650
• NIH Device Record Key: 71545f42-3946-44f8-96f5-2415fe4529a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis
• Version Model Number: 379.027
• Catalog Number: 379.027
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196901650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994153

FDA Product Code

• KXA: Prosthesis, hip, femoral, resurfacing

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05055196901650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-08-17

On-Brand Devices [Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis]

• 05055196905214: MODULAR INTRODUCER HANDLE (5 PARTS)
• 05055196901650: CUP INTRODUCER HANDLE