Corin TriFit CF Hip Stem 6960011

GUDID 05055343898369

TriFit™ CF Stem Standard Size 11

CORIN LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 05055343898369
• NIH Device Record Key: 8cd0de17-fb66-49ec-b258-a6f13fb63b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corin TriFit CF Hip Stem
• Version Model Number: 6960011
• Catalog Number: 6960011
• 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	05055343898369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173880

FDA Product Code

• MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05055343898369]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-21
• Device Publish Date: 2018-08-21

On-Brand Devices [Corin TriFit CF Hip Stem]

• 05056139231162: TriFit™ CF Rasp (Size 1)
• 05056139231155: TriFit™ CF Rasp (Size 2)
• 05056139231148: TriFit™ CF Rasp (Size 3)
• 05056139231131: TriFit™ CF Rasp (Size 4)
• 05056139231124: TriFit™ CF Rasp (Size 5)
• 05056139231117: TriFit™ CF Rasp (Size 6)
• 05056139231100: TriFit™ CF Rasp (Size 7)
• 05056139231094: TriFit™ CF Rasp (Size 8)
• 05056139231087: TriFit™ CF Rasp (Size 9)
• 05056139231070: TriFit™ CF Rasp (Size 10)
• 05056139231063: TriFit™ CF Rasp (Size 11)
• 05055343898475: TriFit™ CF Stem Lateralized Size 11
• 05055343898468: TriFit™ CF Stem Lateralized Size 10
• 05055343898451: TriFit™ CF Stem Lateralized Size 9
• 05055343898444: TriFit™ CF Stem Lateralized Size 8
• 05055343898437: TriFit™ CF Stem Lateralized Size 7
• 05055343898420: TriFit™ CF Stem Lateralized Size 6
• 05055343898413: TriFit™ CF Stem Lateralized Size 5
• 05055343898406: TriFit™ CF Stem Lateralized Size 4
• 05055343898390: TriFit™ CF Stem Lateralized Size 3
• 05055343898383: TriFit™ CF Stem Lateralized Size 2
• 05055343898376: TriFit™ CF Stem Lateralized Size 1
• 05055343898369: TriFit™ CF Stem Standard Size 11
• 05055343898352: TriFit™ CF Stem Standard Size 10
• 05055343898345: TriFit™ CF Stem Standard Size 9
• 05055343898338: TriFit™ CF Stem Standard Size 8
• 05055343898321: TriFit™ CF Stem Standard Size 7
• 05055343898314: TriFit™ CF Stem Standard Size 6
• 05055343898307: TriFit™ CF Stem Standard Size 5
• 05055343898291: TriFit™ CF Stem Standard Size 4
• 05055343898284: TriFit™ CF Stem Standard Size 3
• 05055343898277: TriFit™ CF Stem Standard Size 2
• 05055343898260: TriFit™ CF Stem Standard Size 1
• 05056139234187: TriFit CF Starter Rasp