GUIDE PIN, Ø3.2mm x 381mm

GUDID 00848665039139

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

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• Primary Device ID: 00848665039139
• NIH Device Record Key: fafe69af-f85d-43a4-9978-c4aa9e963c2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUIDE PIN, Ø3.2mm x 381mm
• Version Model Number: S0100-381
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665039139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021008

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

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• 00848665032727 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, LARGE: 2024-02-19
• 00848665032734 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT,SMALL: 2024-02-19
• 00848665032741 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, MEDIUM: 2024-02-19
• 00848665032758 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, LARGE: 2024-02-19
• 00848665034066 - BENDING TEMPLATE,MINIMALLY INVASIVE CALCANEAL PLATE, EXTRA SMALL: 2024-02-19
• 00848665035988 - VARIABLE ANGLE LOCKING SCREW, 3.5mm x 95mm: 2024-02-19