Lumbar Interbody Fusion System (OLLIF) Graft Tamp 01-09

GUDID 00850014575465

Lumbar Interbody Fusion System (OLLIF) Graft Tamp

ADVANCED RESEARCH MEDICAL LLC

Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable

• Primary Device ID: 00850014575465
• NIH Device Record Key: 75fd23f3-808f-42c1-b7f6-77cd8563e605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Fusion System (OLLIF) Graft Tamp
• Version Model Number: 01-09
• Catalog Number: 01-09
• 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
• Phone: 6124401865
• Email: info@advresmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014575465 [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

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

[00850014575465]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-19
• Device Publish Date: 2021-01-11

Devices Manufactured by ADVANCED RESEARCH MEDICAL LLC

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• 00840239800503 - N/A: 2024-05-03 XL-Shaper - Body
• 00840239800701 - N/A: 2024-05-01 XL-Graft Delivery Tube
• 00840239800657 - N/A: 2024-04-29 XL-Graft Tamp
• 00840239800671 - N/A: 2024-04-29 XL-Flexible Curette - Outer
• 00840239800527 - N/A: 2024-04-26 XL-Articulating Curette
• 00840239800572 - N/A: 2024-04-26 Instrument Platform - Decorticator
• 00840239800510 - N/A: 2024-04-24 XL-Shaper - Blades