COGNiTiON™ Staple System

GUDID 05055662969764

INSERTER 2 LEG X 25MM

ORTHO SOLUTIONS HOLDINGS LIMITED

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 05055662969764
• NIH Device Record Key: e01bb822-9cb3-44bf-b7ab-2da5f6f1ee39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COGNiTiON™ Staple System
• Version Model Number: OS380905-NS
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• 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: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662969764 [Primary]

FDA Product Code

• HXJ: Staple Driver

Sterilization

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

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

[05055662969764]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [COGNiTiON™ Staple System]

• 05055662970029: COGNiTiON STERILISATION CASE LID
• 05055662969955: INSERTER SOCKET WRENCH
• 05055662969948: CURVED OSTEOTOME
• 05055662969924: COGNiTiON STERILISATION CASE BASE
• 05055662969917: STAPLE TAMP
• 05055662969900: STAPLE SIZING TEMPLATE
• 05055662969894: COGNiTiON 2.5 X 70MM PIN
• 05055662969887: COGNiTiON 1.9 X 60MM PIN
• 05055662969870: 4 LEG X 25MM DRILL GUIDE
• 05055662969863: 4 LEG X 20MM DRILL GUIDE
• 05055662969856: 2 LEG X 25MM DRILL GUIDE
• 05055662969849: 2 LEG X 20MM DRILL GUIDE
• 05055662969832: 2 LEG X 15MM DRILL GUIDE
• 05055662969825: 2 LEG X 10MM DRILL GUIDE
• 05055662969818: COGNiTiON COUNTERSINK
• 05055662969801: COGNiTiON 2.7 X 130MM DRILL BIT
• 05055662969795: COGNiTiON 2.0 X 120MM DRILL BIT
• 05055662969788: INSERTER 4 LEG X 25MM
• 05055662969771: INSERTER 4 LEG X 20MM
• 05055662969764: INSERTER 2 LEG X 25MM
• 05055662969757: INSERTER 2 LEG X 20MM
• 05055662969740: INSERTER 2 LEG X 15MM
• 05055662969733: INSERTER 2 LEG X 10MM
• 05055662969726: COGNiTiON 4 LEG STAPLE 25MM X 20MM
• 05055662969719: COGNiTiON 4 LEG STAPLE 20MM X 20MM
• 05055662969702: COGNiTiON 4 LEG STAPLE 20MM X 15MM
• 05055662969696: COGNiTiON 2 LEG STAPLE 25MM X 20MM
• 05055662969689: COGNiTiON 2 LEG STAPLE 20MM X 20MM
• 05055662969672: COGNiTiON 2 LEG STAPLE 20MM X 15MM
• 05055662969665: COGNiTiON 2 LEG STAPLE 15MM X 15MM
• 05055662969658: COGNiTiON 2 LEG STAPLE 10MM X10MM