Pacifica™ PACHIMP

GUDID 10889981062644

Pacifica Hybrid Implant

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981062644
• NIH Device Record Key: cdf3f002-5996-41ff-9493-cf3ee33b8338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pacifica™
• Version Model Number: PACHIMP
• Catalog Number: PACHIMP
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981062644 [Primary]

FDA Product Code

• OJH: Orthopedic tray

Sterilization

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

[10889981062644]

Moist Heat or Steam Sterilization

[10889981062644]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

On-Brand Devices [Pacifica™]

• 10889981062651: Pacifica Implant
• 10889981062644: Pacifica Hybrid Implant
• 10889981031619: Pacifica Implant 9mm x 24mm x 14mm