Trinity-i Acetabular Shell 321.04.354

GUDID 05055343870617

Trinity-i Acetabular Shell Ø54mm Taper Size 4

CORIN LTD

Acetabular shell

• Primary Device ID: 05055343870617
• NIH Device Record Key: 5b225962-1b8e-4fd5-a83b-c7701566f57b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity-i Acetabular Shell
• Version Model Number: 321.04.354
• Catalog Number: 321.04.354
• 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: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055343870617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122305

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

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

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

Radiation Sterilization

[05055343870617]

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 [Trinity-i Acetabular Shell]

• 05055343871157: TRINITY-i ACETABULAR SHELL TRIAL SIZE 4/54mm
• 05055343871140: TRINITY-i ACETABULAR SHELL TRIAL SIZE 3/50mm
• 05055343871133: TRINITY-i ACETABULAR SHELL TRIAL SIZE 2/46mm
• 05055343870617: Trinity-i Acetabular Shell Ø54mm Taper Size 4
• 05055343870600: Trinity-i Acetabular Shell Ø50mm Taper Size 3
• 05055343870594: Trinity-i Acetabular Shell Ø46mm Taper Size 2