Lumbar Interbody Fusion System (OLLIF) Oblique 33 mm Implants in Caddy O-3300

GUDID 00850014575342

Lumbar Interbody Fusion System (OLLIF) Oblique 33 mm Implants in Caddy

ADVANCED RESEARCH MEDICAL LLC

Instrument tray

• Primary Device ID: 00850014575342
• NIH Device Record Key: 5c6761dd-6d5c-4710-8341-8b8c7e937b97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Fusion System (OLLIF) Oblique 33 mm Implants in Caddy
• Version Model Number: O-3300
• Catalog Number: O-3300
• Company DUNS: 117201206
• Company Name: ADVANCED RESEARCH MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014575342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173947

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

[00850014575342]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-12-16

Devices Manufactured by ADVANCED RESEARCH MEDICAL LLC

• 00840239800855 - Advanced Research Medical Trident SI Screw System: 2024-10-07 Trident Basket
• 00840239800862 - Advanced Research Medical Trident SI Screw System: 2024-10-02 Trident Primary Screw Caddy and Lid
• 00840239800879 - Advanced Research Medical Trident SI Screw System: 2024-10-02 Trident Instrument Platform
• 00840239800480 - N/A: 2024-06-06 Instrument Platform - Transfacet
• 00840239800695 - N/A: 2024-05-31 XL-Access Portal
• 00840239800763 - N/A: 2024-05-13 1/4" Square QC Fixed Palm Handle
• 00840239800503 - N/A: 2024-05-03 XL-Shaper - Body
• 00840239800701 - N/A: 2024-05-01 XL-Graft Delivery Tube