iPassage 23-40-0001-228

GUDID 10889981111991

S.S Guide Wire iPassage Retractor

Seaspine Orthopedics Corporation

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10889981111991
• NIH Device Record Key: 17b9b098-c292-4300-a3a1-526a614a5f37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iPassage
• Version Model Number: 23-40-0001-228
• Catalog Number: 23-40-0001-228
• 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: false
• 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
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• 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	10889981111991 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

[10889981111991]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-08
• Device Publish Date: 2025-11-29

Devices Manufactured by Seaspine Orthopedics Corporation

• 10889981111991 - iPassage: 2025-12-08S.S Guide Wire iPassage Retractor
• 10889981111991 - iPassage: 2025-12-08 S.S Guide Wire iPassage Retractor
• 10889981332952 - Virata: 2025-10-06 Tulip, Polyaxial
• 10889981332969 - Virata: 2025-10-06 Set Screw
• 10889981333270 - Virata: 2025-10-06 Guidewire, Nitinol, Trochar, 350mm
• 10889981333287 - Virata: 2025-10-06 Guidewire, Nitinol, Trochar, 500mm
• 10889981333294 - Virata: 2025-10-06 Guidewire, Nitinol, Trochar, 600mm
• 10889981333324 - Virata: 2025-10-06 Reducer Handle, Egg
• 10889981333331 - Virata: 2025-10-06 Reducer Handle, T