Zyranox Zirconia Ceramic Femoral Heads E064.128

GUDID 05055196928756

ZIRCONIA MOD HEAD STANDARD 28mm Eurocone Taper

CORIN LTD

Ceramic femoral head prosthesis

• Primary Device ID: 05055196928756
• NIH Device Record Key: 732570cd-fa9b-4068-9269-8f2ffec180fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyranox Zirconia Ceramic Femoral Heads
• Version Model Number: E064.128
• Catalog Number: E064.128
• 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
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196928756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992235

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

Radiation Sterilization

[05055196928756]

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

On-Brand Devices [Zyranox Zirconia Ceramic Femoral Heads]

• 05055196928879: ZIRCONIA MOD HEAD LO
• 05055196928862: ZIRCONIA MOD HEAD LO
• 05055196928855: ZIRCONIA MOD HEAD ST
• 05055196928848: ZIRCONIA MOD HEAD ST
• 05055196928831: ZIRCONIA MOD HEAD SHORT
• 05055196928824: ZIRCONIA MOD HEAD SHORT
• 05055196928787: ZIRCONIA MOD HEAD SHORT 32mm Eurocone Taper
• 05055196928770: ZIRCONIA MOD HEAD SHORT 28mm Eurocone Taper
• 05055196928763: ZIRCONIA MOD HEAD STANDARD 32mm Eurocone Taper
• 05055196928756: ZIRCONIA MOD HEAD STANDARD 28mm Eurocone Taper
• 05055196928749: ZIRCONIA MOD HEAD LONG 32mm Eurocone Taper
• 05055196928732: ZIRCONIA MOD HEAD LONG 28mm Eurocone Taper