SILICONE PALM HANDLE 3/16 SQUARE QUICK CONNECT

GUDID 00848665034165

ADVANCED ORTHOPEDIC SOLUTIONS INC

Drilling power tool attachment, basic

• Primary Device ID: 00848665034165
• NIH Device Record Key: 3ca133d0-cdac-49a1-99d3-97c34496b218
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILICONE PALM HANDLE 3/16 SQUARE QUICK CONNECT
• Version Model Number: 0486-100
• 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
• 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	00848665034165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021008

FDA Product Code

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

Sterilization

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

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

[00848665034165]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-30
• Device Publish Date: 2018-10-30

On-Brand Devices [SILICONE PALM HANDLE 3/16 SQUARE QUICK CONNECT]

• 00848665034165: 0486-100
• 00848665010589: 0486