Tri-plus

GUDID 00822409016396

36mm +3 CoCr

Ortho Development Corporation

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 00822409016396
• NIH Device Record Key: 0ea8f7b9-1835-4362-9e1f-6f1a8a42956d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-plus
• Version Model Number: 138-3603
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• 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: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409016396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042565

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [Tri-plus]

• 00822409016433: 36mm -6 CoCr
• 00822409016426: 36mm -3 CoCr
• 00822409016419: 36mm +9 CoCr
• 00822409016402: 36mm +6 CoCr
• 00822409016396: 36mm +3 CoCr
• 00822409016389: 36mm +0 CoCr
• 00822409016372: 32mm -6 CoCr
• 00822409016365: 32mm -3 CoCr
• 00822409016358: 32mm +9 CoCr
• 00822409016341: 32mm +6 CoCr
• 00822409016334: 32mm +3 CoCr
• 00822409016327: 32mm +0 CoCr
• 00822409016310: 28mm -6 CoCr
• 00822409016303: 28mm -3 CoCr
• 00822409016297: 28mm +9 CoCr
• 00822409016280: 28mm +6 CoCr
• 00822409016273: 28mm +3 CoCr
• 00822409016266: 28mm +0 CoCr
• 00822409016259: 12/14 CoCr Fem Head 26mm -3
• 00822409016242: 12/14 CoCr Fem Head 26mm +9mm
• 00822409016235: 12/14 CoCr Fem Head 26mm +6mm
• 00822409016228: 12/14 CoCr Fem Head 26mm +3mm
• 00822409016211: 12/14 CoCr Fem Head 26mm +0mm
• 00822409016204: 12/14 CoCr Fem Head 22mm -3
• 00822409016198: 12/14 CoCr Fem Head 22mm +6
• 00822409016181: 12/14 CoCr Fem Head 22mm +3
• 00822409016174: 12/14 CoCr Fem Head 22mm + 0