Corin Austin Moore Fenestrated Prosthesis (Cobalt 108.649

GUDID 05055196928039

AUSTIN MOORE STANDAR

CORIN LTD

Uncoated hip femur prosthesis, one-piece

• Primary Device ID: 05055196928039
• NIH Device Record Key: 03f8a734-ed93-4b1d-ad2c-c316fb10c1f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corin Austin Moore Fenestrated Prosthesis (Cobalt
• Version Model Number: 108.649
• Catalog Number: 108.649
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: rachel.king@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196928039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931752

FDA Product Code

• KWL: Prosthesis, hip, hemi-, femoral, metal

Sterilization

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

[05055196928039]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

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