REAMER SHAFT EXTENSION, LARGE HUDSON

GUDID 00848665034325

ADVANCED ORTHOPEDIC SOLUTIONS INC

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 00848665034325
• NIH Device Record Key: c722a44d-06e1-4e2e-a59e-2c64ac3b977a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAMER SHAFT EXTENSION, LARGE HUDSON
• Version Model Number: 4012-100
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665034325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070444

FDA Product Code

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

Sterilization

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

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

[00848665034325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-22
• Device Publish Date: 2019-01-22

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

• 00848665027679 - COUNTERSINK: 2020-06-23
• 00848665000658 - AOS Drill, AO Style, 2.9mm x 100mm: 2020-06-08
• 00848665001235 - AOS CANCELLOUS TAP 3.5mm: 2020-06-08
• 00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH: 2020-06-08
• 00848665028041 - T10 Screwdriver, Short: 2020-06-08
• 00848665028096 - 3.5mm Calibrated Drill: 2020-06-08
• 00848665028119 - AOS 2.6mm Solid Reamer: 2020-06-08
• 00848665028782 - T10 Screwdriver, Solid: 2020-06-08