FUSIO SI Allograft System BI0002

GUDID 00810152100028

ALLOGRAFT INSERTER INNER SHAFT

PROMETHEAN RESTORATIVE LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00810152100028
• NIH Device Record Key: b54a7c67-9b2f-465e-ac40-2b08d0a79a63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUSIO SI Allograft System
• Version Model Number: BI0002
• Catalog Number: BI0002
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810152100028 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

[00810152100028]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-28
• Device Publish Date: 2024-10-18

On-Brand Devices [FUSIO SI Allograft System]

• 00810152100189: 5MM DRILL
• 00810152100172: DILATOR
• 00810152100165: TRIAL / GRAFT PUSHER
• 00810152100141: Instrument Tray Lid
• 00810152100134: Instrument Tray
• 00810152100127: Guidewire, DIA 2.8mm X 250mm
• 00810152100110: Guidewire, DIA 3.2mm X 250mm
• 00810152100103: Jacob's Chuck Handle
• 00810152100097: Tuning Fork
• 00810152100080: Broach
• 00810152100073: Graft Pusher
• 00810152100066: Dilator
• 00810152100059: Guide Tube
• 00810152100042: 6MM DRILL
• 00810152100035: ALLOGRAFT TRIAL, 9MM
• 00810152100028: ALLOGRAFT INSERTER INNER SHAFT
• 00810152100004: ALLOGRAFT INSERTER