CoCr Modular Head extra short E321.328

GUDID 05055343885123

Trinity CoCrMo Modular Head 28mm EXTRA LONG +7.0mm

CORIN LTD

Metallic femoral head prosthesis

• Primary Device ID: 05055343885123
• NIH Device Record Key: 72f437ea-88f0-4276-b5ec-de6ba7a0645c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoCr Modular Head extra short
• Version Model Number: E321.328
• Catalog Number: E321.328
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055343885123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131647

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

[05055343885123]

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 [CoCr Modular Head extra short]

• 05055343885123: Trinity CoCrMo Modular Head 28mm EXTRA LONG +7.0mm
• 05055343885116: Trinity CoCrMo Modular Head 40mm EXTRA SHORT -8.0mm
• 05055343885109: Trinity CoCrMo Modular Head 36mm EXTRA SHORT -8.0mm
• 05055343885093: Trinity CoCrMo Modular Head 32mm EXTRA SHORT -6.0mm
• 05055343885086: Trinity CoCrMo Modular Head 28mm EXTRA SHORT -5.0mm