Trinity-i Acetabular Shell 921.04.354

GUDID 05055343871157

TRINITY-i ACETABULAR SHELL TRIAL SIZE 4/54mm

CORIN LTD

Acetabulum prosthesis trial, 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