Proximal Humeral Plate Expansion Kit Tray

GUDID 00848665028034

ADVANCED ORTHOPEDIC SOLUTIONS INC

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• Primary Device ID: 00848665028034
• NIH Device Record Key: f1386b4c-6e30-4ec0-b6ab-9320bf777e6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Humeral Plate Expansion Kit Tray
• Version Model Number: 9941
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPEDIC SOLUTIONS INC
• 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: (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
• 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
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665028034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080590

FDA Product Code

• KTW: Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

[00848665028034]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-04-30

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• 00848665028782 - T10 Screwdriver, Solid: 2020-06-08