AOS DISTAL DRILL GUIDE 4.0mm

GUDID 00848665001440

ADVANCED ORTHOPEDIC SOLUTIONS INC

Surgical drill guide, reusable

• Primary Device ID: 00848665001440
• NIH Device Record Key: 5e618975-5733-4589-b779-5079f5caaf45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS DISTAL DRILL GUIDE 4.0mm
• Version Model Number: 0315-100
• 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: false
• 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	00848665001440 [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

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

[00848665001440]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-12-21

On-Brand Devices [AOS DISTAL DRILL GUIDE 4.0mm]

• 00848665001440: 0315-100
• 00848665001365: 0308-100