Trinity-i Acetabular Shell 921.04.354

GUDID 05055343871157

TRINITY-i ACETABULAR SHELL TRIAL SIZE 4/54mm

CORIN LTD

Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable

• Primary Device ID: 05055343871157
• NIH Device Record Key: c1e26ce5-677e-479c-9fdd-85a90a47abba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity-i Acetabular Shell
• Version Model Number: 921.04.354
• Catalog Number: 921.04.354
• 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
• 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
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055343871157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122305

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: false

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

[05055343871157]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• 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