Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade 01-06-4

GUDID 00850014575311

Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade

ADVANCED RESEARCH MEDICAL LLC

Bone curette, single-use

• Primary Device ID: 00850014575311
• NIH Device Record Key: b0c662b7-7c5c-4300-8fc7-76100713845e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade
• Version Model Number: 01-06-4
• Catalog Number: 01-06-4
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014575311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173947

FDA Product Code

• HTF: Curette
• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

Moist Heat or Steam Sterilization

[00850014575311]

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

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• 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