CAPTURING ROD, GALILEO® LAG SCREW

GUDID 00848665036473

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

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• Primary Device ID: 00848665036473
• NIH Device Record Key: e201c3f7-3ac3-4907-a549-ea289760f0b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPTURING ROD, GALILEO® LAG SCREW
• Version Model Number: 5033-000
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
• 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: 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: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665036473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202099

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

[00848665036473]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [CAPTURING ROD, GALILEO® LAG SCREW]

• 00848665036473: 5033-000
• 00848665039177: 5033-100