REAMER HEAD 10.0mm

GUDID 00848665000870

ADVANCED ORTHOPEDIC SOLUTIONS INC

Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible

• Primary Device ID: 00848665000870
• NIH Device Record Key: b6bd3fa6-33ae-43c5-854d-8b74548ed3b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAMER HEAD 10.0mm
• Version Model Number: 0234-100
• 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	00848665000870 [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

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

Moist Heat or Steam Sterilization

[00848665000870]

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 10.0mm]

• 00848665000870: 0234-100
• 00848665000641: 0223-100