Lumbar Interbody Fusion System (OLLIF) Flexible Curette-Knob 01-06-3

GUDID 00850014575434

Lumbar Interbody Fusion System (OLLIF) Flexible Curette-Knob

ADVANCED RESEARCH MEDICAL LLC

Bone curette, reusable

• Primary Device ID: 00850014575434
• NIH Device Record Key: 2bb68fa9-9933-4442-b1d8-f03bf4f3fd40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Fusion System (OLLIF) Flexible Curette-Knob
• Version Model Number: 01-06-3
• Catalog Number: 01-06-3
• Company DUNS: 117201206
• Company Name: ADVANCED RESEARCH MEDICAL 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: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014575434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173947

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument
• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

[00850014575434]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-13
• Device Publish Date: 2020-08-05

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