FUSIO™ SI Allograft System CPS0003

GUDID 00810152101261

GUIDE TUBE

PROMETHEAN RESTORATIVE LLC

Surgical drill guide, reusable

• Primary Device ID: 00810152101261
• NIH Device Record Key: 001020e8-0c13-4986-83f0-5db544adee9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUSIO™ SI Allograft System
• Version Model Number: CPS0003
• Catalog Number: CPS0003
• Company DUNS: 124592779
• Company Name: PROMETHEAN RESTORATIVE LLC
• 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: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810152101261 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

[00810152101261]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-13
• Device Publish Date: 2025-03-05

On-Brand Devices [FUSIO™ SI Allograft System]

• 00810152101353: JACOB'S CHUCK HANDLE
• 00810152101346: TRIAL / GRAFT PUSHER
• 00810152101339: GUIDE TUBE TAP CAP
• 00810152101322: DILATOR 9" LENGTH
• 00810152101315: 5MM DRILL
• 00810152101308: GUIDEWIRE - BEVEL TIP, DIA 2.8mm X 335mm
• 00810152101292: GUIDEWIRE - ROUND TIP, DIA 2.8mm X 335mm
• 00810152101285: TUNING FORK
• 00810152101278: BROACH
• 00810152101261: GUIDE TUBE
• 00810152101254: ALLOGRAFT INSERTER, INNER SHAFT
• 00810152101247: ALLOGRAFT INSERTER