LAG SCREW INSERTER, TROCHANTERIC NAIL

GUDID 00848665034080

ADVANCED ORTHOPEDIC SOLUTIONS INC

Surgical screwdriver, reusable

• Primary Device ID: 00848665034080
• NIH Device Record Key: bbfd29a2-d2d2-4a34-9d54-06dd1f190af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LAG SCREW INSERTER, TROCHANTERIC NAIL
• Version Model Number: 0463-200
• 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	00848665034080 [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

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

Moist Heat or Steam Sterilization

[00848665034080]

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 [LAG SCREW INSERTER, TROCHANTERIC NAIL]

• 00848665034080: 0463-200
• 00848665023985: 0463-100
• 00848665010701: 0463
• 00848665035155: 0463-300