REAMER HEAD 9.0mm

GUDID 00848665000856

ADVANCED ORTHOPEDIC SOLUTIONS INC

Medullary canal orthopaedic reamer, flexible

• Primary Device ID: 00848665000856
• NIH Device Record Key: 4a5bcd6b-b32a-4798-ba04-68dd72c76380
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAMER HEAD 9.0mm
• Version Model Number: 0234-090
• 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: 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	00848665000856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012190

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

[00848665000856]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-02-23

On-Brand Devices [REAMER HEAD 9.0mm]

• 00848665000856: 0234-090
• 00848665000627: 0223-090