Trinity with XL Heads E321.340

GUDID 05055196937956

Trinity CoCrMo Modular Head 40mm EXTRA LONG +8.0mm 12/14 Eurocone Taper

CORIN LTD

Metallic femoral head prosthesis

• Primary Device ID: 05055196937956
• NIH Device Record Key: 80799920-e979-4cb9-9035-956cb0694938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity with XL Heads
• Version Model Number: E321.340
• Catalog Number: E321.340
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196937956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130343

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

[05055196937956]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-08-17

On-Brand Devices [Trinity with XL Heads]

• 05055196937956: Trinity CoCrMo Modular Head 40mm EXTRA LONG +8.0mm 12/14 Eurocone Taper
• 05055196937918: Trinity CoCrMo Modular Head 36mm EXTRA LONG +8.0mm 12/14 Eurocone Taper
• 05055196937123: Trinity CoCr Modular Head Ø32mm EXTRA LONG +7.0mm 12/14 Eurocone Taper