Zyranox Zirconia Ceramic Femoral Heads 164.232

GUDID 05055196928879

ZIRCONIA MOD HEAD LO

CORIN LTD

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 05055196928879
• NIH Device Record Key: 908d1b65-b227-48d5-a4d2-e5d286f178f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyranox Zirconia Ceramic Femoral Heads
• Version Model Number: 164.232
• Catalog Number: 164.232
• 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	05055196928879 [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

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

Radiation Sterilization

[05055196928879]

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