TRIFIT STEM E090.125T

GUDID 05055196963047

Tri-Fit Hip Stem

CORIN LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 05055196963047
• NIH Device Record Key: 02391b6d-02e6-4d26-83a4-01df14805d2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIFIT STEM
• Version Model Number: E090.125T
• Catalog Number: E090.125T
• 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	05055196963047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010243

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: true

[05055196963047]

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 [TRIFIT STEM]

• 05055196963078: Tri-Fit Hip Stem
• 05055196963061: Tri-Fit Hip Stem
• 05055196963054: Tri-Fit Hip Stem
• 05055196963047: Tri-Fit Hip Stem
• 05055196963030: Tri-Fit Hip Stem
• 05055196963023: Tri-Fit Hip Stem